AAMI ISO 81060-1 : 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NON INVASIVE SPHYGMOMANOMETERS - PART 1: REQUIREMENTS AND TEST METHODS FOR NON-AUTOMATED MEASUREMENT TYPE
Hardcopy , PDF
31-08-2021
English
01-01-2013
Glossary of equivalent standards
Committee representation
Background of AAMI Adoption of ISO 81060-1:2007
AAMI inclusion to ISO 81060-1:2007
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Identification and marking
4.1 Units of measurement
4.2 Legibility of markings
4.3 Durability of markings
4.4 Marking of non-automated sphygmomanometer
4.5 Usability of reading
4.6 Marking of the cuff
4.7 Marking of the non-automated sphygmomanometer
packaging
5 General requirements for testing non-automated
sphygmomanometers
5.1 Type tests
5.2 Representative sample
5.3 Environmental conditions
5.4 Repairs and modifications
5.5 Humidity preconditioning treatment
6 General requirements
6.1 General
6.2 Electrical safety
6.3 Mechanical safety
6.4 Mechanical strength
7 Requirements
7.1 Pressure indicating means
7.2 Pneumatic system
7.3 Tamper proofing or unauthorized access
7.4 Dynamic response in normal use
8 Additional requirements for non-automated
sphygmomanometer with mercury manometer
8.1 Internal diameter of the tube containing mercury
8.2 Portable non-automated sphygmomanometer
8.3 Prevention of mercury spillage during transport
8.4 Prevention of mercury spillage in normal use
8.5 Quality of the mercury
9 Non-automated sphygmomanometers with aneroid manometer
9.1 Scale mark at zero
9.2 Zero
9.3 Hysteresis error
9.4 Construction and materials
10 Cleaning, sterilization and disinfection
10.1 Reusable non-automated sphygmomanometer and parts
10.2 Non-automated sphygmomanometer and parts requiring
processing before use
10.3 Non-automated sphygmomanometer and parts delivered
sterile
11 Biocompatibility
12 Information supplied by the manufacturer
12.1 Accompanying document
12.2 Instructions for use
12.3 Technical description
Annex A (informative) - Rationale and guidance
Annex B (informative) - Advice regarding non-automated
sphygmomanometers with a mercury
manometer
Annex C (informative) - Environmental aspects
Annex D (informative) - Reference to the essential principals
Annex E (informative) - Terminology - Alphabetized index of
defined terms
Bibliography
Describes the requirements for non-automated sphygmomanometers, as defined in 3.11, and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.
| Committee |
WG 07
|
| DocumentType |
Standard
|
| Pages |
54
|
| ProductNote |
Reconfirmed 2007
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 81060-1:2007 | Identical |
| ISO 7010:2011 | Graphical symbols Safety colours and safety signs Registered safety signs |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| IEC 60721-3-7:1995+AMD1:1996 CSV | Classification of environmental conditions - Part 3-7: Classification of groups of environmental parameters and their severities - Portable and non-stationary use |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| IEC 60601-2-30:1999 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
| IEC 60601-2-34:2011 | Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
| ISO 21647:2004 | Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors |
| CR 13825:2000 | Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings" |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| IEC 60721-3-0:1984+AMD1:1987 CSV | Classification of environmental conditions - Part 3: Classification of groups of environmental parameters and their severities - Introduction |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
| IEC TR 60721-4-7:2001+AMD1:2003 CSV | Classification of environmental conditions - Part 4-7: Guidance for the correlation and transformation of environmental condition classes of IEC 60721-3 to the environmental tests of IEC 60068 - Portable and non-stationary use |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
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