Committee
|
CTN 111 |
Document Type
|
Standard |
ISBN
|
|
Pages
|
|
Published
|
|
Publisher
|
Asociacion Espanola de Normalizacion
|
Status
|
Superseded |
Superseded By
|
|
ISO 11608-4:2006
|
Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
ISO 8537:2016
|
Sterile single-use syringes, with or without needle, for insulin |
ISO 14253-1:2017
|
Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
ISO 11608-1:2014
|
Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
IEC 62366:2007+AMD1:2014 CSV
|
Medical devices - Application of usability engineering to medical devices |
ISO 11608-2:2012
|
Needle-based injection systems for medical use Requirements and test methods Part 2: Needles |
ISO 11608-3:2012
|
Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers |
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
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 |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
ISO/IEC Guide 98-3:2008
|
Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
Unfortunately, this product is not available for purchase in your region.
-
Access your standards online with a subscription
Features
- Simple online access to standards, technical information and regulations
- Critical updates of standards and customisable alerts and notifications
- Multi - user online standards collection: secure, flexibile and cost effective