M/467 - Medical beds

The scope of this TR is a Public Transport common glossary to harmonise terms and definitions from existing data dictionaries.
The methodology consisting of highlighting the differences between various use contexts arises from a number of factors, many of them practical:
1) The facts of history. Many of the legislations, as noted (especially EU Regulations, EC Delegated Regulations and EC Implementing Decisions), already have mandatory application of varying scope, and the regulatory bodies would be most unlikely to consider it worthwhile to actually modify them in line with some list of precise terms developed after the fact.
2) The diversity of practices and use-cases which have been included in the Public Transport domain. Especially as a result of the need for this domain to cover multi-modality and developing technologies, and the increasing requirement for Public Transport to interact with wider domains such as Road Traffic Management, there are bound to be some deeply embedded terms which have been used in different senses in different domains.
3) The differing nature and working practices involved in the legislative, regulatory and technical standardisation processes, and their relationship both to one another and to real-world implementors of Public Transport services.
4) The prior existence of a well-established and precise set of Conceptual Models, including terms and definitions, in the Transmodel ecosystem. This is self-consistent and clearly defined and is being maintained on a continuous basis. However, its use in a legislative context is by “delegation”, which may do little to decrease the possibility of regulations themselves making use of some terms in a sense not intended by Transmodel itself.
The format of the glossary will be structured around following sections:
-   Contexts: Summary of the contexts in which the term or phrase is defined.
-   Related terms: Phrases in which the term is used, either as an element in a compound (e.g. the term “access” vs “access right” or where a related term is used which carries a notably different association (e.g. the term “access” vs “accessibility”, where the latter has a precise meaning in some contexts).
-   Concept: Where it is possible to identify a unifying concept among the various definitions. An informal or explanatory summary of that concept. Where it is not possible, a note of that fact.
-   Harmonisation: Containing references and links to the definitions in their contexts and the suggested conventions for citing them in contexts other than those where they are defined.
-   Source references: Links to definitions of the exact term in their contexts.
-   Usage recommendations: Recommendations for how the terms should be cited in contexts outside that in which the term is defined.

201.1 Scope, object and related standards Clause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows: 201.1.1 * Scope Replacement: This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201). This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions. This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm. NOTE 1 The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT. If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard. This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52). This Standard does not apply to : - incubators covered by EN 60601-2-19 ; - beds for children, covered by EN 716-1 and EN 716-2 ; - cribs and cradles covered by EN 1130 (all parts) ; - bunk beds and high beds, covered by EN 747-1 and 747-2. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006. NOTE 2 See also 4.2 of EN 60601-1:2006. NOTE 3 Body length is measured from crown to sole.

IEC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

201.1   Scope, object and related standards
Clause 1 of EN 60601-1:2006, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, applies, except as follows:
201.1.1   * Scope
Replacement:
This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.
This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.
NOTE 1   The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.
If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard.
This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52).
This Standard does not apply to :
-   incubators covered by EN 60601-2-19 ;
-   beds for children, covered by EN 716-1 and EN 716-2 ;
-   cribs and cradles covered by EN 1130 (all parts) ;
-   bunk beds and high beds, covered by EN 747-1 and 747-2.
If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BEDS and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of EN 60601-1:2006.
NOTE 2   See also 4.2 of EN 60601-1:2006.
NOTE 3   Body length is measured from crown to sole.

IEC 60601-2-52:2009 applies to the basic safety and essential performance of medical beds intended for adults. This first edition cancels and replaces the first edition of IEC 60601-2-38, published in 1996, and its Amendment 1 (1999). This edition constitutes a technical revision. IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.

The scope of this TR is a Public Transport common glossary to harmonise terms and definitions from existing data dictionaries.
The methodology consisting of highlighting the differences between various use contexts arises from a number of factors, many of them practical:
1) The facts of history. Many of the legislations, as noted (especially EU Regulations, EC Delegated Regulations and EC Implementing Decisions), already have mandatory application of varying scope, and the regulatory bodies would be most unlikely to consider it worthwhile to actually modify them in line with some list of precise terms developed after the fact.
2) The diversity of practices and use-cases which have been included in the Public Transport domain. Especially as a result of the need for this domain to cover multi-modality and developing technologies, and the increasing requirement for Public Transport to interact with wider domains such as Road Traffic Management, there are bound to be some deeply embedded terms which have been used in different senses in different domains.
3) The differing nature and working practices involved in the legislative, regulatory and technical standardisation processes, and their relationship both to one another and to real-world implementors of Public Transport services.
4) The prior existence of a well-established and precise set of Conceptual Models, including terms and definitions, in the Transmodel ecosystem. This is self-consistent and clearly defined and is being maintained on a continuous basis. However, its use in a legislative context is by “delegation”, which may do little to decrease the possibility of regulations themselves making use of some terms in a sense not intended by Transmodel itself.
The format of the glossary will be structured around following sections:
-   Contexts: Summary of the contexts in which the term or phrase is defined.
-   Related terms: Phrases in which the term is used, either as an element in a compound (e.g. the term “access” vs “access right” or where a related term is used which carries a notably different association (e.g. the term “access” vs “accessibility”, where the latter has a precise meaning in some contexts).
-   Concept: Where it is possible to identify a unifying concept among the various definitions. An informal or explanatory summary of that concept. Where it is not possible, a note of that fact.
-   Harmonisation: Containing references and links to the definitions in their contexts and the suggested conventions for citing them in contexts other than those where they are defined.
-   Source references: Links to definitions of the exact term in their contexts.
-   Usage recommendations: Recommendations for how the terms should be cited in contexts outside that in which the term is defined.