|
Committee
|
CTN 91 |
|
Development Note
|
Supersedes UNE EN 13503-6. (01/2008) |
|
Document Type
|
Standard |
|
ISBN
|
|
|
Pages
|
|
|
Published
|
|
|
Publisher
|
Asociacion Espanola de Normalizacion
|
|
Status
|
Current |
|
Supersedes
|
|
|
ISO 11607-2:2006
|
Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
|
ASTM F 1929 : 2015 : REDLINE
|
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
|
ISO 2233:2000
|
Packaging Complete, filled transport packages and unit loads Conditioning for testing |
|
ISO/TR 22979:2017
|
Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
|
ISO 10993-12:2012
|
Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
|
ISO 11979-1:2006
|
Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
ISO 2248:1985
|
Packaging Complete, filled transport packages Vertical impact test by dropping |
|
ISO 8318:2000
|
Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency |
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