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Association of Indian Medical Device Industry (AIMED)

Abstracts Of Regulatory Report – July 2011

BS EN Publications  
BS EN ISO 8362-6:2011 Injection containers and accessories. Caps made of aluminium-plastics combinations for injection vials.
No current standard is superseded.
BS EN ISO 13212:2011 Ophthalmic optics. Contact lens care products. Guidelines for determination of shelf life.
Supersedes the dual numbered standard BS EN ISO 13212:1999, BS

 

7208-20:1999  
BS EN 60601-2-45:2011 Medical electrical equipment. Particular requirements for the basic safety and essential performance of mammographic stereotactic devices.
Supersedes the dual numbered standard BS EN 60601-2-45:2001, BS 5724-2-45:2001
BS Implementations  
BS ISO 12891-1:2011 Implants for surgery. Retrieval and analysis of surgical implants. Retrieval and handling.
No current standard is superseded.
British Standards reviewed and confirmed.  
BS EN 14079:2003 Non-active medical devices. Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze.
Corrigenda to British Standards.  
BS EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance.
CORRIGENDUM 1
BS EN 62304:2006 Medical device software. Software life-cycle processes.
CORRIGENDUM 1
British Standards under review  
BS EN ISO 11143:2008 Dental equipment. Amalgam separators.
DD CEN ISO/TS 22367:2010 Medical laboratories. Reduction of error through risk management and continual improvement.
BS ISO 7176-5:2008 Wheelchairs. Determination of dimensions, mass and manoeuvring space.
Draft British Standards for Public Comment  
11/30193833 DC
BS EN ISO 3630-2;
Dentistry. Endodontic instruments. Enlargers
New work started.  
EN ISO 14644-8 Cleanrooms and associated controlled environments. Classification of airborne molecular contamination.
Will supersede BS EN ISO 14644-8:2006
EN 60601-2-41:2009/A1 Medical electrical equipment. Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis.
EN 62220-1-1 Medical electrical equipment. Characteristics of digital X-ray imaging devices. Determination of the detective quantum efficiency. Detectors used in radiographic
imaging.
Will supersede BS EN 62220-1:2004
ISO 5366-3 Anaesthetic and respiratory equipment. Tracheostomy tubes. Paediatric tracheostomy tubes.
ISO 17304 Dentistry. Polymerisation shrinkage of filling materials.
ISO/TS 23810 Cardiovascular implants and artificial organs. Checklist for preoperative extracorporeal circulation equipment setup.
IEC Publications  
IEC 60601-2-34:2011
(Edition 3)
Medical electrical equipment. Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment.
ISO Standards  
ISO 11979-8:- Ophthalmic implants. Intraocular lenses. Fundamental requirements.

 

  AMENDMENT 1:May 2011 to ISO 11979-8:2006.
Will be implemented as an identical British Standard.
ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products.
Will be implemented as an identical British Standard.
ISO/TS 19218-1:2011 Medical devices. Hierarchical coding structure for adverse events. Event-type codes.
Will be implemented as an identical British Standard.
ISO 23908:2011 Sharps injury protection. Requirements and test methods. Sharps protection features for single use hypodermic needles, introducers for catheters and needles used for
blood sampling.
Will be implemented as an identical British Standard.

 

Other News

Solvay Advanced Polymers and Secant Medical Announce marketing partnership in biomedical fabrics
New Grade of Polycarbonate from Bayer MaterialScience LLC Meets Growing Trend for Thinner Walls in Medical Devices
India, Canada To Launch R&D Projects In Biotech, Medical Devices
Stanford Brings Affordable Medical Innovation To India Through Collaborative Design
i2india views poor commercial seed-stage financing key hurdle to growth of medical devices
US FDA provides updated safety data on silicone gel-filled breast implants
Senator tells FDA to Seek Medical Device Industry's Expertise Before Changing 510(k) Process
Implant Mimics Cancellous and Cortical Bone
Microtest Labs announces new fast-track toxicity testing for medical devices using Zebrafish embryos
Madras High Court stays extension given to DCGI until further orders
Biomaterials Research Update: New Wound Healing Materials at Purdue
India-LAC Pharma Business Meet

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