VDI 5700 Blatt 2:2017-06

Superseded

View Superseded by

Reprocessing hazards - Risk management in reprocessing of medical devices - Trainings

Available format(s)

Hardcopy , PDF

Superseded date

03-03-2023

Language(s)

German - English

Published date

06-01-2017

Publisher

Verlag des Vereins Deutscher Ingenieure

Preliminary note
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 Training categories and training
prerequisites
6 Qualification of experts
7 Quality characteristics of training
courses and instructions
8 Training subjects and contents
9 Examinations
10 Certificates
Annex A - Training subjects and contents
Annex B - Certificate template
Bibliography

Applies to courses for further training of staff in the field of reprocessing of medical devices (process-related training) and of staff of medical devices manufacturers, particularly developers (device-related training).

DocumentType	Standard
Pages	16
PublisherName	Verlag des Vereins Deutscher Ingenieure
Status	Superseded
SupersededBy	VDI-MT 5700 Blatt 2:2023-03
Supersedes	VDI 5700 Blatt 2:2016-04 (Draft)

DIN EN ISO 17664:2016-06 (Draft)	PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017)
DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
VDI 5700 Blatt 1:2015-04	Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
VDI 1000:2017-02	VDI Standardisation Work - Principles and procedures
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)