EN 60601-1-8:2007 (IEC 60601-1-8:2006)
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
| Status: | Harmonized EN 60601-1-8:2007 replaces EN 60601-1-8:2004 (Canceled) |
| Poznámka: |
| Full text EAD: | |
| Sector of EN 60601-1-8:2007: | MDD | Medical devices (placed on the market to 26. 5. 2021) |
| Sphere of EN 60601-1-8:2007: | Regulation No. 22/1997 Sb. - harmonized sphere |
| Publications in the Official Journal: |
(EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 |
| Notified bodies (NANDO): | Notified bodies for Council Directive 93/42/EEC |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Council Directive 93/42/EEC
/ repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197
/ amendment (EU)2023/2197 applicable from 9. 11. 2025 / 2020/C/171/1 - Guidelines on the adoption of derogations / Recommendations (EU)2021/1433 wiil gradually expire Recommendations (EU)2020/403 / Recommendations (EU)2020/403 without Corrigendum / Commission Implementing regulation No (EU)2017/2185
/ Regulation Commission No 722/2012
/ Commission Desicion No 2010/227/EU / Agreement No 2017/2118
|
||
|
nařízení vlády č. 54/2015 Sb.
repealed by 89/2021 Coll. from 26th May 2021 |
||
|
Government Regulation SR No 166/2020 Z.z.
// 25. 5. 2021 repealed by No 362/2011 Coll.
|
| Co-existence period end date: | 07.01.2020 (MDD) |
| Released: | December, 2017 |
Changes EN 60601-1-8:2007
| AC:2010 |
(EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 |
|
| A2:2021 |
(EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 |
Zatím neharmonizovaná |
| A11:2017 |
(EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 |
Note
Tato evropská norma nemusí nutně zahrnovat požadavky zavedené směrnicí 2007/47/ES.
ČSN
| ČSN EN 60601-1-8 ed. 2:2008 | |||
| Oprava 1-4.16 | |||
| Změna A11-12.17 | |||
| Změna A1-10.13 | |||
| Změna A2-1.22 |
Customers who have agreed on their computer from ÚNMZ service CSN on-line-for electronic access to the full texts of standards in pdf (version for companies or individuals) may open directly quoted CSN here.