BS EN ISO 11197:2019
Medical supply units
| Standard number: | BS EN ISO 11197:2019 |
| Pages: | 46 |
| Released: | 2019-12-10 |
| ISBN: | 978 0 580 51313 8 |
| Status: | Standard |
BS EN ISO 11197:2019
This standard BS EN ISO 11197:2019 Medical supply units is classified in these ICS categories:
- 11.040.10 Anaesthetic, respiratory and reanimation equipment
IEC 60601‑1:2005+A1:2012, Clause 1 applies except as follows:
201.1.1 Scope
IEC 60601‑1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patientcare services.
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601‑1:2005+A1:2012, 4.2.
201.1.2 Object
IEC 60601‑1:2005+A1:2012, 1.2 is replaced by:
The object of this document is to establish particular basic safety and essential performance requirements for medical supply units as defined in 201.3.201.
201.1.3 Related standards
201.1.3.1 General and Collateral standards
IEC 60601‑1:2005+A1:2012, 1.3 applies as the General Standard with the following addition:
This particular standard refers to those applicable collateral standards that are listed in IEC 60601‑1:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.
IEC 60601‑1‑3:2008+A1:2013, IEC 60601‑1‑8:2006+A1:2012, IEC 60601‑1‑9:2007, IEC 60601‑1‑10:2007+A1:2013 and IEC 60601‑1‑11 and IEC 60601‑1‑12 do not apply.
NOTE Collateral standards are referred to by their document numbers.
201.1.3.2 Particular standards
IEC 60601‑1:2005+A1:2012, 1.4 applies with the following additions:
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 60601‑1:2005+A1:2012 with the prefix “201” (e.g. 201.1 in this standard addresses the content of IEC 60601‑1:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of IEC 60601‑1:2005+A1:2012 are specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard is replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of IEC 60601‑1:2005+A1:2012 or applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of IEC 60601‑1:2005+A1:2012 are numbered starting from 201.101. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.
The term “this standard” is used to make reference to IEC 60601‑1:2005+A1:2012, any applicable collateral standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601‑1:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
IEC 60601‑1:2005+A1:2012, Clause 1 applies except as follows:
201.1.1 Scope
IEC 60601‑1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patientcare services.
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601‑1:2005+A1:2012, 4.2.
201.1.2 Object
IEC 60601‑1:2005+A1:2012, 1.2 is replaced by:
The object of this document is to establish particular basic safety and essential performance requirements for medical supply units as defined in 201.3.201.
201.1.3 Related standards
201.1.3.1 General and Collateral standards
IEC 60601‑1:2005+A1:2012, 1.3 applies as the General Standard with the following addition:
This particular standard refers to those applicable collateral standards that are listed in IEC 60601‑1:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.
IEC 60601‑1‑3:2008+A1:2013, IEC 60601‑1‑8:2006+A1:2012, IEC 60601‑1‑9:2007, IEC 60601‑1‑10:2007+A1:2013 and IEC 60601‑1‑11 and IEC 60601‑1‑12 do not apply.
NOTE Collateral standards are referred to by their document numbers.
201.1.3.2 Particular standards
IEC 60601‑1:2005+A1:2012, 1.4 applies with the following additions:
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 60601‑1:2005+A1:2012 with the prefix “201” (e.g. 201.1 in this standard addresses the content of IEC 60601‑1:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of IEC 60601‑1:2005+A1:2012 are specified by the use of the following words:
“Replacement” means that the clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard is replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of IEC 60601‑1:2005+A1:2012 or applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of IEC 60601‑1:2005+A1:2012 are numbered starting from 201.101. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.
The term “this standard” is used to make reference to IEC 60601‑1:2005+A1:2012, any applicable collateral standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601‑1:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.