BS ISO 12891-1:2015
$167.15
Retrieval and analysis of surgical implants – Retrieval and handling
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 36 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Terms and definitions |
| 10 | 3 Method 3.1 Obtaining the clinical history of the implant and patient 3.2 Pre-explantation checks and examinations 3.3 Collecting the surgical implant |
| 11 | 3.4 Collecting the tissue and fluid samples 3.5 Photographic record of the explantation |
| 12 | 3.6 Containing and labelling the retrieved surgical implant, tissues, and fluids for future identification 3.7 Cleaning the retrieved surgical implant |
| 14 | 3.8 Decontaminating the retrieved surgical implant |
| 15 | 3.9 Packaging the retrieved surgical implant, tissues, and fluids for shipment |
| 16 | 3.10 Use of coolant materials 3.11 Labelling of the packing materials 3.12 Documentation to be supplied with retrieved surgical implants |
| 17 | 3.13 Unpacking following shipment 3.14 Cleaning and decontamination following shipment 3.15 Documentation to be maintained during examination, analysis, and storage 4 Analysis of retrieved surrounding tissues and fluids 5 Infection control 5.1 General |
| 18 | 5.2 Work practices 5.3 Personal protective equipment 5.3.1 General 5.3.2 Gloves 5.3.3 Masks, eye protection, and face shields |
| 19 | 5.3.4 Gowns, aprons, and other protective body clothing 5.4 Maintenance of the worksite 5.4.1 Cleaning and disinfection of worksites 5.4.2 Protective coverings 5.4.3 Equipment and tools |
| 20 | 5.4.4 Reusable receptacles 5.4.5 Contaminated glassware 5.4.6 Reusable items 5.4.7 Contaminated materials 5.5 Human waste disposal |
| 21 | 5.6 Special practices |
| 22 | Annex A (informative) Suggested minimum information to be obtained for retrieved surgical implants |
| 25 | Annex B (informative) Generic procedures for the decontamination of surgical implants |
| 31 | Annex C (informative) Analyses to be performed on retrieved tissue samples and fluids |
| 32 | Bibliography |
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BS ISO 12891-1:2015 – TC:2020 Edition
Tracked Changes. Retrieval and analysis of surgical implants – Retrieval and handling Published By Publication…
