VDI 5700 Blatt 1:2015-04
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control
Hardcopy , PDF
05-04-2023
German - English
04-01-2015
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Preliminary note
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Abbreviations
5 General conditions and basics of risk
management for reprocessing
of medical devices
6 Risk model
7 Characteristics considered
8 Possible Hazards
9 Type of damage for assessment of a the
severity of damage
10 Conduct of risk assessment
11 Recommended measures
for risk control
12 Risk-benefit assessment
in exceptional situations
Bibliography
Aims to areas where responsibility for the safety of reprocessable medical devices and the processes used has to be carried.
| DevelopmentNote |
Supersedes VDI 5700. (04/2015)
|
| DocumentType |
Standard
|
| Pages |
0
|
| PublisherName |
Verlag des Vereins Deutscher Ingenieure
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| VDI 5700 Blatt 2:2017-06 | Reprocessing hazards - Risk management in reprocessing of medical devices - Trainings |
| ISO 15883-1:2006 | Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
| EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| DIN EN 556-1:2002-03 | Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 1: Requirements for terminally sterilized medical devices; English version of DIN EN 556-1 |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 5840:2005 | Cardiovascular implants Cardiac valve prostheses |
| DIN EN ISO 5840:2009-08 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
| DIN EN 285:2016-05 | Sterilization - Steam sterilizers - Large sterilizers |
| 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) |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| DIN EN ISO 14971:2013-04 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
| PREN 285 : DRAFT 2013 | STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| DIN EN ISO 17665-1:2006-11 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| VDI 1000:2017-02 | VDI Standardisation Work - Principles and procedures |
| EN ISO 5840:2009 | Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
| DIN EN ISO 11607-2:2014-11 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| DIN EN ISO 15883-1:2014-10 | WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006 + AMD 1:2014) |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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