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Association of Indian Medical Device Industry

Standards Up-date

BS EN Publications
BS EN 455:- Medical gloves for single use.
BS EN 455-4:2009 Requirements and testing for shelf life determination.
No current standard is superseded
BS EN ISO 9168:2009 Dentistry. Hose connectors for air driven dental handpieces.
Supersedes BS EN 29168:1994.
BS EN ISO 10139:- Dentistry. Soft lining materials for removable dentures.
BS EN ISO 10139-2:2009 Materials for long-term use.
Supersedes BS EN ISO 10139-2:2001
BS EN ISO 10940:2009 Ophthalmic instruments. Fundus cameras.
Supersedes BS EN ISO 10940:1998
BS EN ISO 10944:2009 Ophthalmic instruments. Synoptophores.
Supersedes BS EN ISO 10944:1998
Updated British Standards
BS EN 13795:- Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment.
BS EN 13795-1:2002+A1:2009 General requirements for manufacturers, processors and products.
AMENDMENT 1
BS EN 13795-2:2004+A1:2009 Test methods.
AMENDMENT 1
BS EN 13795-3:2006+A1:2009 Performance requirements and performance levels.
AMENDMENT 1
British Standards withdrawn
BS EN 29168:1994 Dental handpieces. Hose connectors.
British Standards under review
BS EN ISO 3826-3:2007 Blood bag systems with integrated features.
BS EN ISO 5356:- Anaesthetic and respiratory equipment. Conical connectors.
BS EN ISO 5356-2:2007 Screw-threaded weight-bearing connectors.
BS EN ISO 5366:- Anaesthetic and respiratory equipment. Tracheostomy tubes.
BS EN ISO 5366-1:2009 Tubes and connectors for use in adults.
BS EN ISO 8980:- Ophthalmic optics. Uncut finished spectacle lenses.
BS EN ISO 9997:2000 Dental cartridge syringes.
BS EN ISO 10637:2000 Dental equipment. High and medium volume suction systems.
BS EN ISO 10942:2006 Ophthalmic instruments. Direct ophthalmoscopes.
BS EN ISO 10943:2006 Ophthalmic instruments. Indirect ophthalmoscopes.
BS EN ISO 10993:- Biological evaluation of medical devices.
BS EN ISO 10993-2:2006 Animal welfare requirements.
BS EN ISO 10993-11:2009 Tests for systemic toxicity.
BS EN ISO 11380:1997 Optics and optical instruments. Ophthalmic optics. Formers.
BS EN ISO 11381:1997 Optics and optical instruments. Ophthalmic optics. Screw threads.
BS EN ISO 11979:- Ophthalmic implants. Intraocular lenses.
BS EN ISO 11979-5:2006 Biocompatibility
BS EN ISO 11979-8:2009 Fundamental requirements.
BS EN ISO 11979-9:2006 Multifocal intraocular lenses.
BS EN ISO 11979-10:2006 Phakic intraocular lenses.
BS EN ISO 12865:2006 Ophthalmic instruments. Retinoscopes.
BS EN ISO 13212-1999 Ophthalmic optics. Contact lens care products. Guidelines for the determination of shelf-life.
BS EN ISO 15004-1:2009 General requirements applicable to all ophthalmic instruments.
BS EN ISO 15087:- Dental elevators.
BS EN ISO 15087-1:2001 General requirements.
BS EN ISO 15098:- Dental tweezers.
BS EN ISO 15098-1:2001 General requirements.
BS EN ISO 15912-2006 Dentistry. Casting investments and refractory die materials.
BS EN ISO 16284:2006 Ophthalmic optics. Information interchange for ophthalmic optical equipment.
BS EN ISO 17665:- Sterilization of health care products. Moist heat.
BS EN ISO 17665-1:2006 Requirements for the development, validation and routine control of a sterilization process for medical devices.
BS EN ISO 18369:- Ophthalmic optics. Contact lenses.
BS EN ISO 21671:2006 Dentistry. Rotary polishers.
DD ISO/TS 10993:- Biological evaluation of medical devices.
DD ISO/TS 10993-20:2006 Principles and methods for immunotoxicology testing for medical devices.


Contact : Forum Coordinator

Association of Indian Medical Device Industry (AIMED)

GL-3, Ashoka Estate, 24, Barakhamba Road, New Delhi - 110001

Email: forumcoordinator@aimedindia.com

Web Site : www.aimedindia.com

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