{"id":198185,"date":"2024-10-19T12:36:59","date_gmt":"2024-10-19T12:36:59","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-81060-1-2007-ra-2013\/"},"modified":"2024-10-25T05:10:09","modified_gmt":"2024-10-25T05:10:09","slug":"aami-81060-1-2007-ra-2013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-81060-1-2007-ra-2013\/","title":{"rendered":"AAMI 81060 1 2007 RA 2013"},"content":{"rendered":"

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 81060-1:2007\/(R)2013, Non-invasive sphygmomanometers\u2014 Part 1: Requirements and test methods for non-automated measurement type <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page
\n <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information
\n <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of AAMI Adoption of ISO 81060-1:2007 <\/td>\n<\/tr>\n
11<\/td>\nAAMI inclusion to ISO 81060-1:2007 <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 *\u00a0Scope
2 Normative references <\/td>\n<\/tr>\n
16<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
19<\/td>\n4 Identification and marking
4.1 *\u00a0Units of measurement
4.2 *\u00a0Legibility of markings <\/td>\n<\/tr>\n
20<\/td>\n4.3 *\u00a0Durability of markings
4.4 *\u00a0Marking of non-automated sphygmomanometer <\/td>\n<\/tr>\n
21<\/td>\n4.5 *\u00a0Usability 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 *\u00a0Type tests
5.2 *\u00a0Representative sample <\/td>\n<\/tr>\n
22<\/td>\n5.3 Environmental conditions
5.4 Repairs and modifications
5.5 *\u00a0Humidity preconditioning treatment
6 General requirements
6.1 General <\/td>\n<\/tr>\n
23<\/td>\n6.2 Electrical safety
6.3 Mechanical safety
6.4 Mechanical strength
6.4.1 *\u00a0Non-automated sphygmomanometers
6.4.2 *\u00a0Non-automated sphygmomanometers for transport <\/td>\n<\/tr>\n
24<\/td>\n6.4.3 *\u00a0Non-automated sphygmomanometers containing a mercury manometer <\/td>\n<\/tr>\n
25<\/td>\n7 Requirements
7.1 Pressure indicating means
7.1.1 *\u00a0Limits of the error of the cuff pressure indication <\/td>\n<\/tr>\n
26<\/td>\n7.1.2 *\u00a0Nominal range and measuring range
7.2 Pneumatic system
7.2.1 *\u00a0Air leakage <\/td>\n<\/tr>\n
27<\/td>\n7.2.2 *\u00a0Pressure reduction rate
7.2.3 *\u00a0Rapid exhaust <\/td>\n<\/tr>\n
28<\/td>\n7.2.4 Cuff
7.2.5 Cuff and bladder <\/td>\n<\/tr>\n
29<\/td>\n7.2.6 *\u00a0Tubing connectors
7.3 *\u00a0Tamper proofing or unauthorized access
7.4 Dynamic response in normal use <\/td>\n<\/tr>\n
30<\/td>\n8 Additional requirements for non-automated sphygmomanometer with mercury manometer
8.1 *\u00a0Internal diameter of the tube containing mercury
8.2 *\u00a0Portable non-automated sphygmomanometer
8.3 *\u00a0Prevention of mercury spillage during transport
8.4 *\u00a0Prevention of mercury spillage in normal use <\/td>\n<\/tr>\n
31<\/td>\n8.5 Quality of the mercury
9 Non-automated sphygmomanometers with aneroid manometer
9.1 *\u00a0Scale mark at zero
9.2 *\u00a0Zero <\/td>\n<\/tr>\n
32<\/td>\n9.3 Hysteresis error
9.4 *\u00a0Construction and materials <\/td>\n<\/tr>\n
33<\/td>\n10 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 <\/td>\n<\/tr>\n
34<\/td>\n12 Information supplied by the manufacturer
12.1 Accompanying document
12.2 Instructions for use
12.2.1 General <\/td>\n<\/tr>\n
36<\/td>\n12.2.2 Cleaning, disinfection and sterilization <\/td>\n<\/tr>\n
37<\/td>\n12.2.3 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 <\/td>\n<\/tr>\n
39<\/td>\nAnnex A Rationale and guidance
Clause 1 Scope
Subclause 3.9 Model or type reference
Subclause 4.1 Units of measurement <\/td>\n<\/tr>\n
40<\/td>\nSubclause 4.2 Legibility of markings
Subclause 4.3 Durability of markings <\/td>\n<\/tr>\n
41<\/td>\nSubclause 4.4 Marking of non-automated sphygmomanometer
Subclause 4.5 Usability of reading
Subclause 5.1 Type tests <\/td>\n<\/tr>\n
42<\/td>\nSubclause 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 <\/td>\n<\/tr>\n
43<\/td>\nSubclause 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 <\/td>\n<\/tr>\n
44<\/td>\nSubclauses 7.2.1 Air leakage and 7.2.2 Pressure reduction rate <\/td>\n<\/tr>\n
45<\/td>\nSubclause 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 <\/td>\n<\/tr>\n
46<\/td>\nSubclause 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 <\/td>\n<\/tr>\n
47<\/td>\nSubclause 12.2.1 General <\/td>\n<\/tr>\n
48<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
49<\/td>\nAnnex C Environmental aspects <\/td>\n<\/tr>\n
50<\/td>\nAnnex D Reference to the essential principals <\/td>\n<\/tr>\n
52<\/td>\nAnnex E Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n
53<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 81060-1:2007\/(R)2013 – Non invasive sphygmomanometers – Part 1: Requirements and test methods for nonautomated measurement type<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2007<\/td>\n54<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198189,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198185","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198185","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198189"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198185"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198185"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198185"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}