BS EN ISO 11197:2016:2018 Edition
$167.15
Medical supply units
| Published By | Publication Date | Number of Pages |
| BSI | 2018 | 36 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 4 | European foreword |
| 5 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 201.1 Scope, object and related standards 201.1.1 Scope 201.1.2 Object 201.1.3 Related standards 201.1.3.1 Collateral standards 201.1.3.2 Particular standards |
| 14 | 201.2 Normative references |
| 15 | 201.3 Terms and definitions |
| 16 | 201.4 General requirements 201.5 General requirements for testing me equipment 201.5.101 Medical supply unit test results |
| 17 | 201.6 Classification of me equipment and me systems 201.6.1 Protection against electric shock 201.7.2.1 Minimum requirements for marking on me equipment and on interchangeable parts 201.7.2.6 Connection to the supply mains 201.7 Me equipment identification, marking and documents |
| 18 | 201.7.2.8 Output connectors 201.7.2.19 Functional earth terminals 201.7.3 Marking on the outside of me equipment or me equipment parts 201.7.9 Accompanying documents 201.7.9.1 General 201.7.9.2 Instructions for use and maintenance |
| 19 | 201.7.9.3 Technical description |
| 20 | 201.8 Protection against electrical hazards from me equipment 201.8.1 Fundamental rule of protection against electric shock 201.8.6 Protection earthing, functional earthing and potential equalization of me equipment 201.8.6.2 Protective earth terminal |
| 21 | 201.8.6.101 Conductors 201.8.6.102 Bus bar |
| 22 | 201.8.10 Components and wiring 201.8.10.7 Insulation of internal wiring |
| 25 | 201.8.11 Main parts, components and layout 201.8.11.1 Isolation from the supply mains |
| 26 | 201.9.1.101 Dynamic forces 201.9.1.102 Impact resistance test 201.9.1.103 Static forces 201.9.1.104 Static load test 201.9.1.105 Mechanical damage 201.9 Protection against mechanical hazards of me equipment and me systems |
| 27 | 201.9.6 Acoustic energy (including infra- and ultrasound) and vibration |
| 28 | 201.9.8 Mechanical hazards associated with support systems 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards 201.11.1 Excessive temperatures in me equipment 201.11.2 Fire prevention 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.13 Hazardous situations and fault conditions 201.13.2 Single fault conditions |
| 29 | 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15.1 Arrangements of controls and indicators of me equipment 201.15.4 me equipment components and general assembly |
| 33 | 201.15.101 Venting 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 202 Medical electrical equipment – part 1-2 General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests 206 Medical electrical equipment – part 1-6 General requirements for basic safety and essential performance – Collateral standard: Usability |
| 34 | Annex AA (informative) Rationale |
| 35 | Bibliography |
