CENELEC
Project
| Reference | EN 60601-2-49 |
|---|---|
| Title | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| Project Number | 22293 |
| Abstract/Scope | IEC 60601-2-49:2011 applies to the basic safety and essential performance requirements of multifunction patient monitoring equipment. It applies to medical electrical equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Medical electrical equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to me equipment for those environments of use. The scope of this standard is restricted to medical electrical equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part. This second edition cancels and replaces the first edition of IEC 60601-2-49, published in 2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005 (third edition). |
| Status |
Approval stage
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Status
| Current Stage code | 5098 |
|---|---|
| Current Stage code date | 2012-05-30 |
| Current Stage code deadline | |
| Deadline date for vote |
Legal
| Directive(s) | MDD (93/42/EEC) |
|---|---|
| Mandate(s) | M/295 |
| Order Voucher |
Details
| IEC Technical Body | IEC/SC 62D |
|---|---|
| Reference Document | IEC 60601-2-49:2011 (EQV) |
| ICS | 11.040.55 - Diagnostic equipment |
| Keywords | Medical; Multifunction; Patient; Monitoring |
| Note | Will supersede EN 60601-2-49:2001 * D141/066: VR dropped - D141/067: CLC/TC 62 & consultants to solve the negative assessment |
| 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) | |
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| date of Availability (DAV) (2) | |
| date of Announcement (DOA) (3) | dor + 3 months |
| date of Publication (DOP) (4) | dor + 9 months |
| date of Withdrawal (DOW) (5) | dor + 36 months |
Relations
| Supersedes | EN 60601-2-49:2001 |
|---|---|
| Superseded by | |
| Normative reference (6) |
(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.
