BS EN ISO 80601-2-69:2014
$198.66
Medical electrical equipment – Particular requirements for basic safety and essential performance of oxygen concentrator equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 58 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | Foreword |
| 5 | Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU Directive 93/42/EEC Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC |
| 7 | Table ZA.2 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to article 3 of amended Directive 93/42/EEC) |
| 14 | 201.1 Scope, object and related standards 201.1. 1 Scope |
| 15 | 201.1. 2 Object 201.1. 3 Collateral standards 201.1. 4 Particular standards |
| 16 | 201.2 Normative references |
| 17 | 201.3 Terms and definitions |
| 18 | 201.4 General requirements 201.4. 3 Essential performance 201.4. 3.101 * Additional requirements for essential performance 201.4. 6 * Me equipment or me system parts that contact the patient |
| 19 | 201.5 General requirements for testing of me equipment 201.5. 101 Additional requirements for general requirements for testing of me equipment 201.5. 101.1 * Me equipment testing errors 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents 201.7. 1.2 * Legibility of markings 201.7. 2.4.101 Additional requirements for accessories 201.7. 2.13.101 Additional requirements for physiological effects |
| 20 | 201.7. 2.101 Additional requirements for marking on the outside of me equipment or me equipment parts |
| 25 | 201.8 Protection against electrical hazards from me equipment 201.9 Protection against mechanical hazards of me equipment and me systems 201.9. 6.2.1.101 Additional requirements for audible acoustic energy |
| 26 | 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards 201.11. 1 Maximum temperature during normal use 201.11. 1.2.2 Applied parts not intended to supply heat to a patient 201.11. 2.101 * Additional requirements for fire prevention |
| 27 | 201.11. 6.4 Leakage 201.11. 6.6 * Cleaning and disinfection of me equipment or me system |
| 28 | 201.11. 6.7 Sterilization of me equipment or me system 201.11. 8.101 Additional requirements for interruption of the power supply/supply mains to me equipment 201.11. 8.101.1 Technical alarm condition for power supply failure 201.11. 8.101.2 Internal electrical power source |
| 29 | 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12. 1 Accuracy of controls and instruments 201.12. 1.101 Accuracy of continuous flowrate |
| 30 | 201.12. 1.102 Accuracy of triggered flowrate 201.12. 1.103 * Accuracy of concentration |
| 32 | 201.12. 1.104 Outlet pressure 201.12. 4 Protection against hazardous output 201.12. 4.4.101 Additional requirements for incorrect output 201.12. 4.4.101.1 Flowrate control 201.12. 4.4.101.2 Indication of start-up period 201.12. 4.102 Low oxygen concentration alarm condition |
| 33 | 201.12. 4.103 Delivered gas filter 201.13 Hazardous situations and fault conditions 201.13. 2.101 Additional specific single fault conditions 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.16 Me systems |
| 34 | 201.16. 1.101 Additional general requirements for me systems 201.17 Electromagnetic compatibility of me equipment and me systems 201.17. 101 Additional requirements for electromagnetic compatibility of me equipment and me systems 201.101 Outlet connector 201.102 Requirements for parts and accessories 201.102. 1 * General 201.102. 2 Labelling |
| 35 | 201.102. 3 * Fire risk reduction in accessories 201.103 Signal input/output part 201.103. 1 General 201.103. 2 * Connection to a distributed alarm system |
| 36 | 201.103. 3 * Connection for remote control 201.104 * Indication of duration of operation 201.105 Integrated conserving equipment 202.6.2.1.10 * Compliance criteria |
| 37 | 211.4.2.2 Environmental operating conditions |
