BS ISO 12891-1:2015
Current
The latest, up-to-date edition.
Retrieval and analysis of surgical implants Retrieval and handling
Hardcopy , PDF
English
30-06-2015
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 Method
4 Analysis of retrieved surrounding tissues and fluids
5 Infection control
Annex A (informative) - Suggested minimum information to
be obtained for retrieved surgical implants
Annex B (informative) - Generic procedures for the
decontamination of surgical implants
Annex C (informative) - Analyses to be performed on
retrieved tissue samples and fluids
Bibliography
Defines the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. Also define the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping.
| Committee |
CH/150
|
| DevelopmentNote |
Supersedes 10/30195943 DC. (05/2011)
|
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This part of ISO 12891 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history, pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. This part of ISO 12891 also provides guidance on infection control.
NOTE National or other regulations, which can be more stringent, can apply.
This part of ISO 12891 does not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.
| Standards | Relationship |
| ISO 12891-1:2015 | Identical |
| ASTM F 561 : 2013 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
| NSF 49 : 2016 | BIOSAFETY CABINETRY: DESIGN, CONSTRUCTION, PERFORMANCE, AND FIELD CERTIFICATION |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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