CENELEC
Project
| Reference | EN 61010-2-101:2002 |
|---|---|
| Title | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| Project Number | 7604 |
| Abstract/Scope | Applies to equipment intended for in vitro diagnostic (IVD) medical purposes. This is used for the examination of specimens, including blood and tissue samples, derived from the human body. The standard also covers self-test IVD medical equipment for use by lay persons. |
| Status |
Published
|
Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 2002-11-15 |
| Current Stage code deadline | 2003-09-01 |
| Deadline date for vote |
Legal
| Directive(s) | IVD (98/79/EC) |
|---|---|
| Mandate(s) | M/095 |
| Order Voucher |
Details
| IEC Technical Body | IEC/TC 66 |
|---|---|
| Reference Document | IEC 61010-2-101:2002 (MOD) |
| ICS | 11.040.55 - Diagnostic equipment 19.080 - Electrical and electronic testing |
| Keywords | Laboratory equipment; Medical equipment; In vitro diagnostic; Measurement; Safety |
| Note | Former prEN 61010-2-081 * D124/130: BTTF 88-1 disbanded - Work referred to SR 66 |
| A-Deviation(s) | |
| Special National Condition(s) |
Environment
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Clause
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Categories - Aspects
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Product Life Cycle
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Information
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|---|
History
Implementation Dates
| date of Ratification (DOR) (1) | 2002-09-01 |
|---|---|
| date of Availability (DAV) (2) | 2002-11-15 |
| date of Announcement (DOA) (3) | 2003-03-01 |
| date of Publication (DOP) (4) | 2003-09-01 |
| date of Withdrawal (DOW) (5) | 2005-09-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | FprEN 61010-2-101:2012 |
| Normative reference (6) |
EN ISO 14971:2000
|
(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.
