BS ISO 8600-1:2015
Current
The latest, up-to-date edition.
Endoscopes. Medical endoscopes and endotherapy devices General requirements
Hardcopy , PDF
English
31-10-2015
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Testing
6 Marking
7 Instruction manual
8 Packaging
Annex A (informative) - Guidelines on the application of
risk management to endoscopic system connector
Bibliography
Provides definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.
| Committee |
CPW/172
|
| DevelopmentNote |
Supersedes 88/55910 DC. (07/2005) Supersedes 04/30105055 DC. (09/2005) Supersedes 12/30228200 DC. (04/2013)
|
| DocumentType |
Standard
|
| Pages |
22
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO8600 gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.
| Standards | Relationship |
| ISO 8600-1:2015 | Identical |
| ISO 8600-4:2014 | Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion |
| IEC 60601-2-18:2009 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| ISO 8600-3:1997 | Optics and optical instruments Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with optics |
| ISO 8600-6:2005 | Optics and photonics Medical endoscopes and endotherapy devices Part 6: Vocabulary |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
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