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No current standard is superseded BS EN ISO 9168:2009 Dentistry.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 AMENDMENT 1 British Standards withdrawn BS EN 29168:1994 Dental handpieces.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 Contd...Next Issue