BSI BS 2646 PART 1 |
Autoclaves for Sterilization in Laboratories Part 1: Specification for Design, Construction, Safety and Performance-Supersedes BS 2646: 1955; |
BSI BS 5295- 0 |
Environmental Cleanliness in Enclosed Spaces - Part 0: General Introduction, Terms and Definitions for Clean Rooms and Clean Air Devices-AMD 10634; March 2000; |
BSI BS 6196 |
Sterile Epidural Catheters and Introducer Needles for Single Use-AMD 6458: November 30, 1990; |
BSI BS EN 1041 |
Information Supplied by the Manufacturer with Medical Devices |
BSI BS EN 1060- 1 |
Non-invasive sphygmomanometers - Part 1: General requirements-AMD 13881: October 8, 2002; Supersedes BS 2743: 1990 |
BSI BS EN 1060- 2 |
Non-Invasive Sphygmomanometers - Part 2: Supplementary Requirements for Mechanical Sphygmomanometers-CORR 14063: December 19, 2002; Together with BS EN 1060-1 Supersedes BS 2743:1990; |
BSI BS EN 1060- 3 |
Non-Invasive Sphygmomanometers Part 3: Supplementary Requirements for Electro-Mechanical Blood Pressure Measuring Systems |
BSI BS EN 1089- 2 |
Transportable Gas Cylinders - Gas Cylinder Identification (Excluding LPG) - Part 2: Precautionary Labels |
BSI BS EN 1174- 1 |
Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 1: Requirements |
BSI BS EN 1174- 2 |
Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 2: Guidance |
BSI BS EN 1174- 3 |
Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product Part 3: Guide to the Methods for Validation of Microbiological Techniques |
BSI BS EN 12006- 1 |
Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 1: Heart Valve Substitutes |
BSI BS EN 12006- 2 |
Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 2: Vascular Prostheses Including Cardiac Valve Conduits |
BSI BS EN 12006- 3 |
Non-Active Surgical Implants - Particular Requirements for Cardiac and Vascular Implants - Part 3: Endovascular Devices |
BSI BS EN 12010 |
Non-Active Surgical Implants - Joint Replacement Implants - Particular Requirements |
BSI BS EN 12011 |
Instrumentation to be Used in Association with Non-Active Surgical Implants - General Requirements |
BSI BS EN 12286 |
1999 In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Presentation of Reference Measurement Procedures-AMD 11034: January 2001; |
BSI BS EN 12287 |
In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials |
BSI BS EN 12342 |
Corr.1 Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators-CORR 10395; December 15, 1998; Supersedes BS 6151: 1992 |
BSI BS EN 12347 |
Biotechnology - Performance Criteria for Steam Sterilizers and Autoclaves |
BSI BS EN 12442- 1 |
Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1: Analysis and Management of Risk |
BSI BS EN 12442- 2 |
Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2: Controls on Sourcing, Collection and Handling |
BSI BS EN 12442- 3 |
Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 3: Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents |
BSI BS EN 12470- 4 |
Clinical Thermometers - Part 4: Performance of Electrical Thermometers for Continuous Measurement |
BSI BS EN 12547 |
Centrifuges - Common Safety Requirements-Corr 1; AMD 10767; October 1999; Supersedes BS 767:1983 |
BSI BS EN 1281- 2 |
Anaesthetic and Respiratory Equipment - Conical Connectors Part 2: Screw-Threaded, Weight-Bearing Connectors (N) |
BSI BS EN 1283 |
Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and Their Extracorporeal Circuits (N) |
BSI BS EN 13274- 1 |
Respiratory Protective Devices - Methods of Test - Part 1: Determination of Inward Leakage and Total Inward Leakage |
BSI BS EN 13427 |
Packaging Requirements for the use of European Standards in the field of packaging and packaging waste |
BSI BS EN 13428 |
Packaging Requirements specific to manufacturing and composition Prevention by source reduction |
BSI BS EN 13429 |
Packaging Reuse |
BSI BS EN 13451- 1 |
Swimming Pool Equipment - Part 1: General Safety Requirements and Test Methods |
BSI BS EN 13532 |
General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing |
BSI BS EN 13544- 2 |
Respiratory Therapy Equipment - Part 2: Tubing and Connectors- Supersedes BS 7711-1:1994; |
BSI BS EN 13544- 3 |
Respiratory Therapy Equipment - Part 3: Air Entrainment Devices- Supersedes BS 7711-2:1994; |
BSI BS EN 13612 |
Performance evaluation of in vitro diagnostic medical devices-CORR 14302: February 27, 2003; |
BSI BS EN 13640 |
Stability Testing of in Vitro Diagnostic Reagents |
BSI BS EN 13726- 1 |
Test Methods for Primary Wound Dressings - Part 1: Aspects of Absorbency |
BSI BS EN 13726- 2 |
Test Methods for Primary Wound Dressings - Part 2: Moisture Vapour Transmission Rate of Permeable Film Dressings |
BSI BS EN 13726- 3 |
Non-active medical devices Test methods for primary wound dressings Part 3: Waterproofness |
BSI BS EN 13726- 4 |
Non-active medical devices Test methods for primary wound dressings Part 4: Conformability |
BSI BS EN 13726- 6 |
Non-active medical devices Test methods for primary wound dressings Part 6: Odour control |
BSI BS EN 13824 |
Sterilization of medical devices Aseptic processing of liquid medical devices Requirements |
BSI BS EN 13868 |
Catheters - Test Methods for Kinking of Single Lumen Catheters and Medical Tubing |
BSI BS EN 13975 |
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
BSI BS EN 14079 |
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
BSI BS EN 14136 |
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
BSI BS EN 1422 |
Sterilizers for medical purposes Ethylene oxide sterilizers Requirements and test methods-CORR 14232: February 25, 2003; Partially Supersedes BS 3970-1: 1990; |
BSI BS EN 14254 |
In vitro diagnostic medical devices Single-use receptacles for the collection of specimens, other than blood, from humans |
BSI BS EN 14299 |
Non active surgical implants Particular requirements for cardiac and vascular implants Specific requirements for arterial stents |
BSI BS EN 144- 1 |
Respiratory protective devices Gas cylinder valves Part 1: Thread connections for insert connector-AMD 14484: August 20, 2003; AMD 15783: November 14, 2005 |
BSI BS EN 1615 |
Enteral Feeding Catheters and Enteral Giving Sets for Single Use and Their Connectors - Design and Testing |
BSI BS EN 1616 |
Sterile Urethral Catheters for Single Use-AMD 10574: August 1999; Supersedes BS 1695: Part 1: 1990 and Part 2: 1990; |
BSI BS EN 1617 |
Sterile Drainage Catheters and Accessory Devices for Single Use |
BSI BS EN 1618 |
Catheters Other than Intravascular Catheters - Test Methods for Common Properties |
BSI BS EN 1639 |
Dentistry Medical devices for dentistry Instruments |
BSI BS EN 1640 |
Dentistry Medical devices for dentistry Equipment |
BSI BS EN 1642 |
Dentistry Medical devices for dentistry Dental implants |
BSI BS EN 1658 |
Requirements for Marking of In Vitro Diagnostic Instruments |
BSI BS EN 1707 |
Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Lock Fittings-Supersedes BS 3930: Part 2:1991; |
BSI BS EN 1822- 1 |
High Efficiency Air Filters (HEPA and ULPA) - Part 1: Classification, Performance Testing, Marking |
BSI BS EN 1822- 2 |
High Efficiency Air Filters (HEPA and ULPA) - Part 2: Aerosol Production, Measuring Equipment, Particle Counting Statistics |
BSI BS EN 1822- 3 |
High Efficiency Air Filters (HEPA and ULPA) - Part 3: Testing Flat Sheet Filter Media |
BSI BS EN 1822- 4 |
High Efficiency Particulate Air Filters (HEPA and ULPA) - Part 4: Determining Leakage of Filter Element (Scan Method) |
BSI BS EN 1822- 5 |
High Efficiency Particulate Air Filters (HEPA and ULPA) - Part 5: Determining the Efficiency of Filter Element |
BSI BS EN 20594- 1 |
Conical Fittings with 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 1: General Requirements-AMD 9881: March 15, 1998; ISO 594-1: 1986; Supersedes BS 3930: 1965 and BS 5081: 1976; |
BSI BS EN 27740 |
Instruments for Surgery, Scalpels with Detachable Blades, Fitting Dimensions-AMD 9907: March 15, 1998; ISO 7440: 1985; Supersedes BS 2982: 1986 |
BSI BS EN 285 |
Sterilization - Steam Sterilizers - Large Sterilizers-Supersedes BS 3970: Part 3: 1990 and the Current Provisions of BS 3970: Part 1: 1990, Which is Subject to Amendment; |
BSI BS EN 28601 |
Data Elements and Interchange Formats - Information Interchange - Representation of Dates and Times (ISO 8601: 1988) (AMD 7825) June 15, 1993 (Formerly BS 7151: 1989 Replaces BS 4760: 1971 and BS 5249: Part 1: 1976) (E) |
BSI BS EN 375 |
Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Professional Use |
BSI BS EN 376 |
Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing |
BSI BS EN 45020 |
Standardization and related activities - General vocabulary-Partially Superseded by BS EN ISO/IEC 17000:2004 |
BSI BS EN 45501 |
Metrological Aspects of Non-Automatic Weighing Instruments (AMD 8343) October 15, 1994 (H)-Amd 1; Supersedes BS 4960:1986; Supersedes BS 6624:1985 |
BSI BS EN 45502- 1 |
Active Implantable Medical Devices Part 1: General Requirements for Safety, Marking and Information to be Provided by the Manufacturer |
BSI BS EN 45502-2- 1 |
Active implantable medical devices Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)- Supersedes BS 6902-1: 1990 and BS 6902-1: Supplement No 1: 1996; |
BSI BS EN 455- 1 |
Medical Gloves for Single Use - Part 1: Requirements and Testing for Freedom from Holes |
BSI BS EN 455- 3 |
Medical Gloves for Single Use - Part 3: Requirements and Testing for Biological Evaluation-Together with BS EN 455-1 and -2, Supersedes BS 4005: 1996; |
BSI BS EN 50077 |
Low Profile Connectors (IS-1) for Implantable Pacemakers (N) |
BSI BS EN 50103 |
Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the Active (Including Active Implantable) Medical Device Industry (N) |
BSI BS EN 50191 |
Erection and Operation of Electrical Test Equipment |
BSI BS EN 550 |
Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization |
BSI BS EN 55011 |
Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Radio Disturbance Characteristics - Limits and Methods of Measurement-AMD 14477: July 23, 2003; |
BSI BS EN 552 |
Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Irradiation-AMD 10623: September 1999; AMD 13085: June 2001 |
BSI BS EN 554 |
Sterilization of Medical Devices - Validation and Routine Control of Sterilization by Moist Heat |
BSI BS EN 556- 1 |
Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices |
BSI BS EN 556- 2 |
Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices |
BSI BS EN 591 |
Instructions for Use for In Vitro Diagnostic Instruments for Professional Use |
BSI BS EN 60068-2- 14 |
Environmental Testing - Part 2: Tests - Test N: Change of Temperature- Supersedes BS 2011-2.1N: 1985 |
BSI BS EN 60068-2- 30 |
Environmental Testing - Part 2: Tests - Test Db and Guidance: Damp Heat, Cyclic (12 + 12 Hour Cycle)-IEC 60068-2-30: 1980, Including Amendment 1: August 1985; Supersedes BS 2011 Part 2.1DB:1981 |
BSI BS EN 60068-2- 33 |
Environmental testing - Part 2: Tests - Guidance on change of temperature tests-Supersedes BS 2011-2.2N: 1977 |
BSI BS EN 60118- 13 |
Electroacoustics Hearing aids Part 13: Electromagnetic compatibility (EMC) |
BSI BS EN 60127- 1 |
Miniature fuses - Part 1: Definitions for miniature fuses and general requirements for minature fuse-links-AMD 14382: May 20, 2003 |
BSI BS EN 60127- 10 |
Miniature Fuses - Part 10: User Guide for Miniature Fuses-IEC 60127- 10:2001; |
BSI BS EN 60127- 2 |
Miniature fuses Part 2: Cartridge fuse-links-AMD 14903: January 14, 2004 |
BSI BS EN 60127- 3 |
Miniature fuses Part 3: Specification for sub-miniature fuse-links-AMD 14530: September 3, 2003; IEC 60127-3: 1988 + A1: 1991 |
BSI BS EN 60127- 6 |
Miniature fuses Part 6: Fuse-holders for miniature cartridge fuse-links- AMD 14513: August 20, 2003; IEC 60127-6: 1994 |
BSI BS EN 60336 |
X-Ray Tube Assemblies for Medical Diagnosis Characteristics of Focal Spots-AMD 8835: October 15, 1995; Renumbers BS 6530:1994; IEC 336: 1993 |
BSI BS EN 60336 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots |
BSI BS EN 60417- 1 |
Graphical Symbols for Use on Equipment - Part 1: Overview and Application-IEC 60417-1:1998; |
BSI BS EN 60417- 2 |
Graphical Symbols for Use on Equipment - Part 2: Symbol Originals-AMD 13942:January 23, 2003; Supersedes BS 6217:1981; IEC 60417-2:1998; |
BSI BS EN 60522 |
Determination of the Permanent Filtration of X-Ray Tube Assemblies-IEC 60522: 1999; |
BSI BS EN 60601- 1 |
Medical Electrical Equipment Part 1: General Requirements for Safety- AMD 6715: December 1990; AMD 7940: November 1995; AMD 9693: October 1997; Renumbers BS 5724: Part 1: 1989 |
BSI BS EN 60601-1- 1 |
Medical Electrical Equipment - Part 1: General Requirements for Safety - Collateral Standard - Safety Requirements for Medical Electrical Systems-Also Known as BS 5724-1-1: 2001 |
BSI BS EN 60601-1- 2 |
Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests-IEC 60601-1- 2: 2001 |
BSI BS EN 60601-1- 3 |
Medical Electrical Equipment Part 1: General Requirements for Safety Section 1.3: Collateral Standard: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment-Also Known as BS 5724: Section 1.3; IEC 601-1-3: 1994 |
BSI BS EN 60601-1- 4 |
Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems-AMD 13000: April 2001; Also Known as BS 5724-1.4:1997; IEC 60601-1-4:1996 |
BSI BS EN 60601-1- 8 |
Medical electrical equipment Part 1-8: General requirements for safety Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
BSI BS EN 60601-2- 10 |
Medical electrical equipment - Part 2.10: Particular requirements for the safety of nerve and muscle stimulators-AMD 14260: March 21, 2003; Renumbers BS 5724- 2.10: 1988; |
BSI BS EN 60601-2- 16 |
Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment-CORR 10991: March 2001; Supersedes BS 5724-2-16: 1989; Also Known as BS 5724-2-16: 1998; IEC 60601-2-16: 19 |
BSI BS EN 60601-2- 17 |
Medical electrical equipment Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment |
BSI BS EN 60601-2- 2 |
Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment |
BSI BS EN 60601-2- 20 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Transport Incubators-Supersedes BS 5724 Section 2.120: 1991; Also Known as BS 5724-2.120: 1997; IEC 601-2-20: 1990 |
BSI BS EN 60601-2- 21 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Infant Radiant Warmers-Also Known as BS 5724: Section 2.121: 1997; IEC 601-2-21: 1995 |
BSI BS EN 60601-2- 22 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2. 122: Specification for Diagnostic and Therapeutic Laser Equipment-Also Known as BS 5724-2.122:1996; Supersedes BS 5724-2.122:1993; IEC 601-2-22:1995 |
BSI BS EN 60601-2- 23 |
Medical Electrical Equipment - Part 2-23: Particular Requirements for the Safety, Including Essential Performance, of Transcutaneous Partial Pressure Monitoring Equipment-Supersedes BS EN 60601-3-1:1997 |
BSI BS EN 60601-2- 25 |
Medical Electrical Equipment - Part 2-25: Particular Requirements for the Safety of Electrocardiographs-AMD 9112: July, 1996; AMD 10844: October, 2000; IEC 60601- 2-25: 1993 |
BSI BS EN 60601-2- 26 |
Medical electrical equipment Part 2-26: Particular requirements for the safety - Specification for electroencephalographs |
BSI BS EN 60601-2- 27 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety - Specification for Electrocardiographic Monitoring Equipment-Also Known as BS 5724: Section 2.127:1995; IEC 601-2-27:1994 |
BSI BS EN 60601-2- 28 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.128: Specification for X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis-Also Known as BS 5724: Section 2.128: 1993; IEC 601-2-28: 1993 |
BSI BS EN 60601-2- 30 |
Medical Electrical Equipment - Part 2-29: Particular Requirements for Safety, Including Essential Performance, of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment-IEC 60601-2-30: 1999 |
BSI BS EN 60601-2- 31 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.31: Specification for External Cardiac Pacemakers with Internal Power Source-AMD 10132: November 1998; Also Known as BS 5724-2.31: 1995; IEC 60601-2-31: 1994 |
BSI BS EN 60601-2- 32 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.32: Specification for Associated Equipment of X-Ray Equipment-Also Known as BS 5724-2.32:1995; IEC 601-2-32: 1994 |
BSI BS EN 60601-2- 44 |
Medical electrical equipment Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography-AMD 14238: February 19, 2003; Also Known as BS 5724-2.44: 2001; |
BSI BS EN 60601-2- 45 |
Medical Electrical Equipment - Part 2-45: Particular Requirements for Safety of Mammographic X-Ray Equipment and Mammographic Stereotactic Devices-Also Known as BS 5724-2-45:2001; IEC 60601-2-45:2001 |
BSI BS EN 60601-2- 49 |
Medical Electrical Equipment - Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment-IEC 60601-2-49:2001; |
BSI BS EN 60601-2- 7 |
Medical Electrical Equipment - Part 2-7: Particular Requirements for Safety - Specification for High Voltage Generators of Diagnostic X-Ray Generators- Supersedes BS 5724-2.7: 1987; Also Known as BS 5724-2.7: 1998; IEC 60601-2-7: 1998; |
BSI BS EN 60601-2- 9 |
Medical Electrical Equipment Part 2: Particular Requirements for Safety Section 2.9: Specification for Patient Contact Dosemeters Used in Radiotherapy with Electrically Connected Radiation Detectors-Supersedes BS 5724: Section 2.9:1988; Also Known as B |
BSI BS EN 60617- 2 |
Graphical Symbols for Diagrams Part 2: Symbol Elements, Qualifying Symbols and Other Symbols Having General Application-Supersedes BS 3939: Part 2: 1985; IEC 617-2: 1996 |
BSI BS EN 60801- 2 |
Electromagnetic Compatibility for Industrial-Process Measurement and Control Equipment Part 2: Electrostatic Discharge Requirements (IEC 801-2: 1991) (F) |
BSI BS EN 61000-3- 11 |
Electromagnetic Compatibility (EMC) - Part 3-11: Limits - Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-Voltage Supply Systems - Equipment with Rated Voltage Current Greater than or Equal to 75 A and Subject to Condition |
BSI BS EN 61000-4- 1 |
Electromagnetic Compatibility (EMC) - Part 4-1: Testing and Measurement Techniques - Overview of IEC 61000-4 Series-IEC 61000-4-1:2000; Supersedes BS 6667 PART 1 |
BSI BS EN 61000-4- 2 |
Electromagnetic Compatibility (EMC) - Part 4.2: Testing and Measurement Techniques - Electrostatic Discharge Immunity Test-AMD 13187: September 28, 2001; IEC 61000-4-2: 1995; |
BSI BS EN 61000-4- 25 |
Electromagnetic Compatibility (EMC) - Part 4-25: Testing and Measurement Techniques - HEMP Immunity Test Methods for Equipment and Systems-IEC 61000-4-25: 2001; |
BSI BS EN 61000-6- 2 |
Electromagnetic Compatibility (EMC) - Part 6-2: Generic Standards - Immunity for Industrial Environments-Supersedes BS EN 61000-6-2:1999, Which Will Remain Current; IEC 61000-6-2:1999 |
BSI BS EN 61000-6- 3 |
Electromagnetic compatibility (EMC) Part 6-3: Generic standards Emission standard for residential, commercial and light-industrial environments-AMD 15429:November 12, 2004; CORR 15540:March 1, 2005; Supersedes BS EN 50081- 1:1992 |
BSI BS EN 61000-6- 4 |
Electromagnetic Compatibility (EMC) - Part 6-4: Generic Standards - Emission Standard for Industrial Environments-Supersedes BS EN 50081-2:1994, But Will Remain Current |
BSI BS EN 61010-2- 041 |
Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 2-041: Particular Requirements for Autoclaves Using Steam for the Treatment of Medical Materials, and for Laboratory Processes-Partically Supersedes BS 2646 |
BSI BS EN 61010-2- 043 |
Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-043: Particular Requirements for Dry Heat Sterilizers Using Either Hot Air or Hot Inert Gas for the Treatment of Medical Materials, and for Laboratory Proce |
BSI BS EN 61508- 1 |
Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems - Part 1: General Requirements-CORR 10631: August 1999; AMD 13779; March 15, 2002; Renumbers BS IEC 61508-1: 1999 |
BSI BS EN 61508- 3 |
Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems - Part 3: Software Requirements-CORR 10630:August 1999; AMD 13781:March 15, 2002; Renumbers BS IEC 61508-3:1998 |
BSI BS EN 724 |
Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for Non-Active Medical Devices (N) |
BSI BS EN 737- 1 |
Medical Gas Pipeline Systems - Part 1: Terminal Units for Compressed Medical Gases and Vacuum-Together with BS EN 739: 1998, it Partially Supersedes BS 5682: 1984: |
BSI BS EN 737- 2 |
Medical Gas Pipeline Systems - Part 2: Anaesthetic Gas Scavenging Disposal Systems - Basic Requirements-AMD 10864, August 2000; Together with BS EN 737-4: 1998 and Clause 111 of BS EN 740: 1998, it Supersedes BS 6834: 1987; |
BSI BS EN 737- 3 |
Medical Gas Pipeline Systems - Part 3: Pipelines for Compressed Medical Gases and Vacuum |
BSI BS EN 738- 1 |
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow metering devices-AMD 13720: October 16, 2002; |
BSI BS EN 738- 2 |
Pressure Regulators for Use with Medical Gases Part 2: Manifold and Line Pressure Regulators-Corr 1; 10802 Corr.No.1, March 2000 |
BSI BS EN 739 |
Low-pressure hose assemblies for use with medical gases-AMD 13722: October 16, 2002; Together with BS EN 737-1: 1998, it Partially Supersedes BS 5682: 1984; |
BSI BS EN 740 |
Anaesthetic workstations and their modules Particular requirements- AMD 15021:July 7, 2004; Supersedes BS 5724-13:1990; Together with BS EN 737-2:1998 and BS EN 737-4:1998 partially supersedes BS 6834:1997; Also known as BS 5724- 2.204:1999 |
BSI BS EN 80416- 1 |
Basic Principles for Graphical Symbols for Use on Equipment - Part 1: Creation of Symbol Originals-IEC 80416-1: 2001; Supersedes BS 7477: 1991; |
BSI BS EN 829 |
In Vitro Diagnostic Systems - Transport Packages for Medical and Biological Specimens - Requirements, Tests |
BSI BS EN 866- 1 |
Biological Systems for Testing Sterilizers and Sterilization Processes Part 1: General Requirements |
BSI BS EN 866- 2 |
Biological Systems for Testing Sterilizers and Sterilization Processes Part 2: Particular Systems for Use in Ethylene Oxide Sterilizers |
BSI BS EN 866- 3 |
Biological Systems for Testing Sterilizers and Sterilization Processes Part 3: Particular Systems for Use in Moist Heat Sterilizers |
BSI BS EN 867- 1 |
Non-Biological Systems for Use in Sterilizers Part 1: General Requirements |
BSI BS EN 867- 2 |
Non-Biological Systems for Use in Sterilizers Part 2: Process Indicators (Class A) |
BSI BS EN 867- 3 |
Non-Biological Systems for Use in Sterilizers Part 3: Specification for Class B Indicators for Use in the Bowie and Dick Test-CORR 10589: January 2000 |
BSI BS EN 867- 4 |
Non-Biological Systems for Use in Sterilizers - Part 4: Specification for Indicators as an Alternative to the Bowie and Dick Test for the Detection of Steam Penetration-Supersedes BS 7720:1995 |
BSI BS EN 867- 5 |
Non-Biological Systems for Use in Sterilizers - Part 5: Specification for Indicator Systems and Process Challenge Devices for Use in Performance Testing for Small Sterilizers Type B and Type S |
BSI BS EN 868- 1 |
Packaging Materials and Systems for Medical Devices Which are to be Sterilized Part 1: General Requirements and Test Methods |
BSI BS EN 868- 10 |
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 10: Adhesive Coated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods |
BSI BS EN 868- 2 |
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 2: Sterilization Wrap - Requirements and Test Methods-Supersedes BS 6254:1989 and BS 6255:1989; |
BSI BS EN 868- 3 |
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 3: Paper for Use in the Manufacture of Paper Bags (Specified in EN 868-4) and in the Manufacture of Pouches and Reels (Specified in EN 868-5) - Requirements and Test |
BSI BS EN 868- 4 |
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4:Paper Bags - Requirements and Test Methods-Supersedes BS 6257: 1989; |
BSI BS EN 868- 5 |
Packaging materials and systems for medical devices which are to be sterilized Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction Requirements and test methods-CORR 14073: January 15, 2003; Supersedes BS 6871: 198 |
BSI BS EN 868- 6 |
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 6: Paper for the Manufacture of Packs for Medical Use for Sterilization by Ethylene Oxide or Irradiation - Requirements and Test Methods |
BSI BS EN 868- 7 |
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 7: Adhesive Coated Paper for the Manufacture of Heat Sealable Packs for Medical Use for Sterilization by Ethylene Oxide or Irradiation - Requirements and Test Methods |
BSI BS EN 868- 8 |
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 8: Re-Usable Sterilization Containers for Steam Sterilizers Conforming to EN 285 - Requirements and Test Methods |
BSI BS EN 868- 9 |
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 9: Uncoated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods |
BSI BS EN 980 |
Graphical Symbols for Use in the Labelling of Medical Devices |
BSI BS EN ISO 10079- 1 |
Medical Suction Equipment - Part 1: Electrically Powered Suction Equipment - Safety Requirements-Also known as BS 5724-2.28:2000 |
BSI BS EN ISO 10555- 1 |
Sterile, Single-Use Intravascular Catheters Part 1: General Requirements- AMD 10805; January 2000; Supersedes BS 7174-1:1990; |
BSI BS EN ISO 10993- 1 |
Biological evaluation of medical devices Part 1: Evaluation and testing |
BSI BS EN ISO 10993- 14 |
Biological Evaluation of Medical Devices - Part 14: Identification and Quantification of Degradation Products from Ceramics-CORR 13748: March 15, 2002 |
BSI BS EN ISO 10993- 15 |
Biological Evaluation of Medical Devices - Part 15: Identification and Quantification of Degradation Products from Metals and Alloys |
BSI BS EN ISO 10993- 8 |
Biological Evaluation of Medical Devices - Part 8: Selection and Qualification of Reference Materials for Biological Tests |
BSI BS EN ISO 11070 |
Sterile, Single-Use Intravascular Catheter Introducers-Supersedes BS 7174-4: 1990; |
BSI BS EN ISO 11608- 2 |
Pen-Injectors for Medical Use - Part 2: Needles - Requirements and Test Methods |
BSI BS EN ISO 11737- 2 |
Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process |
BSI BS EN ISO 11979- 1 |
Ophthalmic Implants - Intraocular Lenses - Part 1: Vocabulary |
BSI BS EN ISO 11979- 4 |
Ophthalmic Implants - Intraocular Lenses - Part 4: Labellings and Information |
BSI BS EN ISO 11980 |
Ophthalmic Optics - Contact Lenses and Contact Lens Care Products - Guidance for Clinical Investigations-Also Known as BS 7208-16: 1998; Supersedes BS 7208 PART 3:1992 |
BSI BS EN ISO 11985 |
Ophthalmic Optics - Contact Lenses - Ageing by Exposure to UV and Visible Radiation (In Vitro Method) |
BSI BS EN ISO 13402 |
Surgical and Dental Hand Instruments - Determination of Resistance Against Autoclaving, Corrosion and Thermal Exposure-AMD 13008: March 2001; Renumbers BS 7891: 1997 |
BSI BS EN ISO 13485 |
Medical devices Quality management systems Requirements for regulatory purposes |
BSI BS EN ISO 13488 |
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002-Supersedes BS EN 46002: 1997; ISO 13488: 1996 |
BSI BS EN ISO 14155- 1 |
Clinical investigation of medical devices for human subjects Part 1: General requirements-CORR 14481: May 15, 2003; Supersedes BS EN 540: 1993; |
BSI BS EN ISO 14155- 2 |
Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans |
BSI BS EN ISO 14644- 1 |
Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness-CORR 13013: March 2001; Supersedes BS 5295-1:1989 and BS 5295-4:1989; |
BSI BS EN ISO 14644- 2 |
Cleanrooms and Associated Controlled Environments - Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1- Supersedes BS 5295-4:1989; |
BSI BS EN ISO 14644- 4 |
Cleanrooms and associated controlled environments Part 4: Design, construction and start-up-CORR 14472: May 1, 2003; Supersedes BS 5295-2:1989; BS EN ISO 14644-4:2001 together with BS EN ISO 14644-5:2004 Supersedes DD ENV 1631:1996 |
BSI BS EN ISO 14644- 5 |
Cleanrooms and associated controlled environments Part 5: Operations- Supersedes BS 5295-3:1989, It together with BS EN ISO 14644-4:2004, Supersedes DD ENV 1631:1996 |
BSI BS EN ISO 14729 |
Ophthalmic Optics - Contact Lens Care Products - Microbiological Requirements and Test Methods for Products and Regimens for Hygienic Management of Contact Lenses-Also Known as BS 7208-26:2001; Supersedes BS 7208 PART 3:1992 |
BSI BS EN ISO 14937 |
Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices-CORR 13353:September 2001; CORR 15195:June 16, 20 |
BSI BS EN ISO 14971 |
Medical Devices - Application of Risk Management to Medical Devices-CORR 14652; August 19, 2003 |
BSI BS EN ISO 15225 |
Nomenclature Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange-AMD 15036: March 31, 2004 |
BSI BS EN ISO 1797- 1 |
Dental Rotary Instruments - Shanks Part 1: Shanks Made of Metals-AMD 10704: January 2000; Supersedes BS 6828: Part 1: 1987; |
BSI BS EN ISO 21647 |
Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors-Supersedes BS EN 12598:1999, BS EN 864:1997 and BS EN ISO 11196:1997 |
BSI BS EN ISO 4135 |
Anaesthetic and Respiratory Equipment - Vocabulary |
BSI BS EN ISO 5356- 1 |
Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
BSI BS EN ISO 7153- 1 |
Surgical Instruments - Metallic Materials - Part 1: Stainless Steel-AMD 13007: March 2001; Renumbers BS 5194-1:1991 |
BSI BS EN ISO 7405 |
Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials-Supersedes BS 5828: 1989; |
BSI BS EN ISO 780 |
Packaging - Pictorial Marking for Handling of Goods-Supersedes BS EN 20780: 1993; |
BSI BS EN ISO 7886- 2 |
Sterile Hypodermic Syringes for Single Use Part 2: Syringes for Use with Power-Driven Syringe Pumps-AMD 9835 November 1997; Renumbers BS ISO 7886-2: 1996; |
BSI BS EN ISO 8320- 2 |
Contact Lenses and Contact Lens Care Products - Vocabulary - Part 2: Contact Lens Care Products-Also Known as BS 7208-19:2001; Together with BS EN ISO 8320-1 Supersedes BS 3521-3:1988; Supersedes BS 7208 PART 3:1992 |
BSI BS EN ISO 8536- 3 |
Infusion Equipment for Medical Use - Part 3: Aluminium Caps for Infusion Bottles-Corr 1; AMD 10829; April 2000; |
BSI BS EN ISO 9000 |
Quality management systems - Fundamentals and vocabulary |
BSI BS EN ISO 9000 |
Quality management systems - Fundamentals and vocabulary- Supersedes BS EN ISO 8402: 1995; |
BSI BS EN ISO 9913- 2 |
Optics and Optical Instruments - Contact Lenses - Part 2: Determination of Oxygen Permeability and Transmissibility by the Coulometric Method-Also Known as BS 7208-23:2000 |
BSI BS EN ISO/IEC 17000 |
Conformity assessment Vocabulary and general principles-Partially Supersedes BS EN 45020:1998 |
BSI BS EN ISO/IEC 17011 |
Conformity assessment General requirements for accreditation bodies accrediting conformity assessment bodies-Supersedes BS EN 45003:1995, BS EN 45010:1998 and PD 6642:1999 |
BSI BS EN ISO/IEC 17025 |
General requirements for the competence of testing and calibration laboratories |
BSI BS EN ISO/IEC 17050-1 |
Conformity assessment Supplier s declaration of conformity Part 1: General requirements-Together with BS EN ISO/IEC 17050-2:2004 Supersedes BS EN 45014:1998 |
BSI BS EN ISO/IEC 17050-2 |
Conformity assessment Supplier s declaration of conformity Part 2: Supporting documentation-Together with BS EN ISO/IEC 17050-1:2004 supersedes BS EN 45014:1998 |
BSI BS ISO 14879- 1 |
Implants for Surgery - Total Knee-Joint Prostheses - Part 1: Determination of Endurance Properties of Knee Tibial Trays |
BSI BS ISO 3534- 3 |
Statistics - Vocabulary and Symbols - Part 3: Design of Experiments |
BSI BS ISO 9000- 2 |
Quality Management and Quality Assurance Standards - Part 2: Generic Guidelines for the Application of ISO 9001, ISO 9002 and ISO 9003-Supersedes BS 5750 : Part 4: 1994; |
BSI PD ISO/TS 29001 |
Petroleum, petrochemical and natural gas industries Sector-specific quality management systems Requirements for product and service supply organizations |