CENELEC
Project
| Reference | EN 50077:1993 |
|---|---|
| Title | Low-profile connector for implantable cardiac pacemakers |
| Project Number | 4257 |
| Abstract/Scope | This European standard specifies a connector assembly to be used to connect implantable pacemaker leads to implantable pulse generators. Essential dimensions and performance requirements are specified, together with appropriate test methods. However, this standard does not address all aspects of the functional compatibility and reliability of different leads and pulse generators assembled into a pacemaker system: in particular, this standard does not specify certain essential features, such as the means of fastening the connector assembly, or the materials of construction. WARNING The connector cavity specified in this standard is not to be used with an implantable device if that device is capable of introducing dangerous non-pacing signals (e.g. defibrillation signals) through an IS-1 connector. This European standard supplements EN 50061 only for those pacemaker components which are claimed by their labelling to be fitted with an IS-1 connector assembly part. It does not replace any requirement in EN 50061 regarding leads. |
| Status |
Published
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Status
| Current Stage code | 6060 |
|---|---|
| Current Stage code date | 1993-06-04 |
| Current Stage code deadline | 1993-12-01 |
| Deadline date for vote |
Legal
| Directive(s) | |
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| Mandate(s) | |
| Order Voucher | BC/CLC/02-89 |
Details
| IEC Technical Body | IEC/SC 62D |
|---|---|
| Reference Document | |
| ICS | |
| Keywords | Medical; Pacemaker; Cardiac; Implantable; Low-profile connector |
| Note | Corrigendum to EN issued November 1993 |
| 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
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Stage
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Date
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Deadline Date
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Documents
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|---|---|---|---|
| 6060 | 1993-06-04 | 1993-12-01 |  EN |
| 6020 | 1992-04-24 | 1992-07-24 | |
| 5099 | 1992-03-24 | 1992-04-24 | |
| 5091 | 1991-12-10 | 1992-06-10 | |
| 5020 | 1991-06-20 | 1991-10-30 | |
| 3090 | 1991-03-15 | 1991-09-15 | |
| 5099 | 1990-12-10 | 1991-01-10 | |
| 5020 | 1990-06-15 | 1990-09-30 | |
| 4099 | 1990-03-05 | 1990-08-05 | |
| 5020 | 1989-05-25 | 1989-11-30 |
Implementation Dates
| date of Ratification (DOR) (1) | 1992-03-24 |
|---|---|
| date of Availability (DAV) (2) | 1993-06-04 |
| date of Announcement (DOA) (3) | 1992-04-01 |
| date of Publication (DOP) (4) | 1993-12-01 |
| date of Withdrawal (DOW) (5) | 1993-12-01 |
Relations
| Supersedes | |
|---|---|
| Superseded by | |
| Normative reference (6) |
EN 50061:1988
|
(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.
