Catalog of standards
Catalog of standards
11
HEALTH CARE TECHNOLOGY
11.040
Medical equipment
11.040.01
Medical equipment in general
| Reference number of the normative document | Title of the normative document | Կարգավիճակը | Developer of the normative document and its address | Price in Armenian drams (AMD) (including VAT) |
Cart |
| GOST EN 556-1-2011 | Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices | Active |
|
2000 |
Russian |
| AST ISO 13485-2018 | Medical devices - Quality management systems - Requirements for regulatory purposes | Active |
National Institute of Standards CJSV (Yerevan) 2004 c. Yrevan, Komitas str. 49/4 |
39500 |
Armenian |
| GOST ISO 14971-2021 | Medical devices. Application of risk management to medical devices | Active |
|
13200 |
Russian |
| AST GOST R ISO 15223-1-2023 | Medical devices. Symbols to be used with information to be supplied by the manufacturer. Part 1. General requirements | Active |
|
17600 |
Russian |
| GOST 16940-2023 | Sanitary stretchers. General technical requirements and test methods | Active |
|
2800 |
Russian |
| GOST 31214-2016 | Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity | Active |
|
2400 |
Russian |
| AST GOST R 50444-2023 | Medical instruments, apparatus and equipment. General technical requirements | Active |
|
10400 |
Russian |
| GOST IEC 60601-1-2024 | Medical electrical equipment. Part 1. General requirements for basic safety and essential performance | Active |
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| GOST IEC 60601-1-8-2022 | Medical electrical equipment. Part 1-8. General requirements for basic safety and essential performance. Collateral standard. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | Active |
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| AST GOST R IEC 60601-2-36-2023 | Medical electrical equipment. Part 2-36. Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy | Active |
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| GOST IEC 62304-2022 | Medical devices. Software. Life cycle processes | Active |
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| AST GOST R IEC 62366-1-2023 | Medical devices. Part 1. Application of usabilityengineering to medical devices | Active |
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