| General : | |
| Version: | 1.0 |
| Project : | |
| Author: | Wolfgang Kern |
| Status: | Approved |
| Created: | 11.07.2014 11:40:14 |
| Modified: | 00:00:00 |
| Advanced : | |
| Appears In: | 4.2.2 General requirement for RISK MANAGEMENT |
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EA Project Browser
Overview- Organisation Chart
- Staff
- Roles
- Projects
- SOPs
- Templates
- Software tools
- Equipment
- Facilities
- Products
- Compliance
Compliance
ISO 13485:2016-08 Qualitätsmanagement- ISO 13485:2012-11 Quality management
- ISO 14971 Risk management
- IEC 62304 Software life-cycle processes
- IEC 62366 Usability
- CFR 820 Code of Federal Regulations Title 21
- Council directive 93/42/EEC, Annex II
- ISO 27001 Information technology - Security techniques
- IEC 60601-1 Processes
- IEC 60601-1-Processes
- 4.2.2 General requirement for RISK MANAGEMENT
- 4.3 Essential Performance
- 4.4 Expected Service Life
- 4.6 ME Equipment or ME System parts that contact the patient
- 4.7 Single fault condition
- 4.9 Use of components with high-integrity characteristics
- 5.1 Type Tests
- 7.1.1 Usability of identification, marking and documents
- 7.1.2 Legibility of markings
- 7.2.2 Identification
- 7.9.2.1 Instructions for use - General
- 7.9.2.15 Environmental protection
- 7.9.2.2 Warning and safety notices
- 8.5.1.1 Separation of parts (MOP)
- 11.1.2.2 Temperature of apllied parts not intended to supply heat to a patient
- 12.2 Usability of ME equipment
- 13.1.2 Emissions, deformation of ENCLOSURE or exceeding maximum temperature
- 13.2.6 Leakage of liquid
- 14 PEMS
- 15 Construction of ME equipment
- 17 Electromagnetic compatibility of ME equipment and ME systems
- Sandbox