CENELEC
Project
| Reference | EN 80601-2-30:2010 |
|---|---|
| Title | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| Project Number | 21531 |
| Abstract/Scope | IEC 80601-2-30:2009 applies to the basic safety and essential performance of automated sphygmomanometers, which by means of an inflatable cuff are used for intermittent indirect measurement of the blood pressure without arterial puncture. It covers electrically-powered intermittent, indirect measurement of the blood pressure without arterial puncture, me equipment with automatic methods for estimating blood pressure, including blood pressure monitors for the home healthcare environment. This first edition of IEC 80601-2-30 cancels and replaces the second edition of IEC 60601-2-30, published in 1999. This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system. |
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Published
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Status
| Current Stage code | 6060 |
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| Current Stage code date | 2010-09-10 |
| Current Stage code deadline | 2011-06-01 |
| Deadline date for vote |
Legal
| Directive(s) | MDD pending (93/42/EEC) |
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| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62D |
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| Reference Document | IEC 80601-2-30:2009 (EQV) + corrigendum Jan. 2010 (EQV) |
| ICS | 11.040 - Medical equipment |
| Keywords | Medical; Safety; Performance; Automated; Sphygmomanometers |
| Note | Supersedes EN 60601-2-30:2000 * IEC 80601-2-30 prepared by a JWG IEC/ISO with IEC lead |
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Environment
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Information
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History
Implementation Dates
| date of Ratification (DOR) (1) | 2010-09-01 |
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| date of Availability (DAV) (2) | 2010-09-10 |
| date of Announcement (DOA) (3) | 2010-12-01 |
| date of Publication (DOP) (4) | 2011-06-01 |
| date of Withdrawal (DOW) (5) | 2013-09-01 |
Relations
| Supersedes | EN 60601-2-30:2000 |
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| Superseded by | |
| Normative reference (6) | ISO 594-1:1986 ISO 594-2:1991 EN 60068-2-27:2009 EN 60068-2-31:2008 EN 60068-2-64:2008 EN 60601-1-2:2007 corr. March 2010 EN 60601-2-2:2009 A11:2011 ISO 81060-2:2009 |
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
