AAMI 81060 1 2007 RA 2013
$131.66
ANSI/AAMI/ISO 81060-1:2007/(R)2013 – Non invasive sphygmomanometers – Part 1: Requirements and test methods for nonautomated measurement type
| Published By | Publication Date | Number of Pages |
| AAMI | 2007 | 54 |
This standard specifies requirements for mechanical sphygmomanometers and their accessories that, by means of an inflatable cuff, are used for the non-invasive measurement of blood pressure. This standard also specifies requirements for the safety, essential performance, effectiveness, and labeling, for these instruments and their accessories, including test methods to determine the accuracy of their measurements. The standard covers non-invasive blood pressure measuring devices with a mechanical pressure sensing element and display used in conjunction with a stethoscope or other manual methods for detecting Korotkoff sounds.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 81060-1:2007/(R)2013, Non-invasive sphygmomanometers— Part 1: Requirements and test methods for non-automated measurement type |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of AAMI Adoption of ISO 81060-1:2007 |
| 11 | AAMI inclusion to ISO 81060-1:2007 |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 * Scope 2 Normative references |
| 16 | 3 Terms and definitions |
| 19 | 4 Identification and marking 4.1 * Units of measurement 4.2 * Legibility of markings |
| 20 | 4.3 * Durability of markings 4.4 * Marking of non-automated sphygmomanometer |
| 21 | 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 |
| 22 | 5.3 Environmental conditions 5.4 Repairs and modifications 5.5 * Humidity preconditioning treatment 6 General requirements 6.1 General |
| 23 | 6.2 Electrical safety 6.3 Mechanical safety 6.4 Mechanical strength 6.4.1 * Non-automated sphygmomanometers 6.4.2 * Non-automated sphygmomanometers for transport |
| 24 | 6.4.3 * Non-automated sphygmomanometers containing a mercury manometer |
| 25 | 7 Requirements 7.1 Pressure indicating means 7.1.1 * Limits of the error of the cuff pressure indication |
| 26 | 7.1.2 * Nominal range and measuring range 7.2 Pneumatic system 7.2.1 * Air leakage |
| 27 | 7.2.2 * Pressure reduction rate 7.2.3 * Rapid exhaust |
| 28 | 7.2.4 Cuff 7.2.5 Cuff and bladder |
| 29 | 7.2.6 * Tubing connectors 7.3 * Tamper proofing or unauthorized access 7.4 Dynamic response in normal use |
| 30 | 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 |
| 31 | 8.5 Quality of the mercury 9 Non-automated sphygmomanometers with aneroid manometer 9.1 * Scale mark at zero 9.2 * Zero |
| 32 | 9.3 Hysteresis error 9.4 * Construction and materials |
| 33 | 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 |
| 34 | 12 Information supplied by the manufacturer 12.1 Accompanying document 12.2 Instructions for use 12.2.1 General |
| 36 | 12.2.2 Cleaning, disinfection and sterilization |
| 37 | 12.2.3 Maintenance 12.2.4 Accessories, supplementary equipment, used material 12.2.5 Environmental protection 12.2.6 Reference to the technical description 12.3 Technical description |
| 39 | Annex A Rationale and guidance Clause 1 Scope Subclause 3.9 Model or type reference Subclause 4.1 Units of measurement |
| 40 | Subclause 4.2 Legibility of markings Subclause 4.3 Durability of markings |
| 41 | Subclause 4.4 Marking of non-automated sphygmomanometer Subclause 4.5 Usability of reading Subclause 5.1 Type tests |
| 42 | Subclause 5.2 Representative sample Subclause 5.5 Humidity preconditioning treatment Subclause 6.4.1 Non-automated sphygmomanometers Subclause 6.4.2 Non-automated sphygmomanometers for transport |
| 43 | Subclause 6.4.3 Non-automated sphygmomanometers containing a mercury manometer Subclause 7.1.1 Limits of the error of the cuff pressure indication Subclause 7.1.2 Nominal range and measuring range |
| 44 | Subclauses 7.2.1 Air leakage and 7.2.2 Pressure reduction rate |
| 45 | Subclause 7.2.3 Rapid exhaust Subclause 7.2.6 Tubing connectors Subclause 7.3 Tamper proofing or unauthorized access Subclause 8.1 Internal diameter of the tube containing mercury |
| 46 | Subclause 8.2 Portable non-automated sphygmomanometer Subclause 8.3 Prevention of mercury spillage during transport Subclause 8.4 Prevention of mercury spillage in normal use Subclause 9.1 Scale mark at zero Subclause 9.2 Zero Subclause 9.4 Construction and materials |
| 47 | Subclause 12.2.1 General |
| 48 | Annex B Advice regarding non-automated sphygmomanometers with a mercury manometer B.1 Guidelines and precautions B.2 Health and safety when handling mercury B.3 Mercury spillage B.4 Cleaning the manometer tube |
| 49 | Annex C Environmental aspects |
| 50 | Annex D Reference to the essential principals |
| 52 | Annex E Terminology — Alphabetized index of defined terms |
| 53 | Bibliography |
