{"id":198229,"date":"2024-10-19T12:37:09","date_gmt":"2024-10-19T12:37:09","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80601-2-30-2018\/"},"modified":"2024-10-25T05:10:18","modified_gmt":"2024-10-25T05:10:18","slug":"aami-80601-2-30-2018","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80601-2-30-2018\/","title":{"rendered":"AAMI 80601 2 30 2018"},"content":{"rendered":"

Applies to basic safety and essential performance of automated sphygmomanometers which are used for the non-invasive blood pressure measurement.<\/p>\n

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1<\/td>\nANSI\/AAMI\/IEC 80601-2-30:2018; Medical electrical equipment\u2014Part 2-30: Particular requirements for the basic safety and essential performance of automated type non-invasive sphygmomanometers <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Untitled <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of IEC 80601-2-30:2018 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n201.1 Scope, object and related standards
201.1. 1 Scope <\/td>\n<\/tr>\n
14<\/td>\n201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards <\/td>\n<\/tr>\n
15<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
16<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
18<\/td>\n201.4 General requirements
201.4. 3 Essential performance
201.4. 3.101 Additional essential performance requirements
Table 201.101 \u2013 Distributed ESSENTIAL PERFORMANCE requirements <\/td>\n<\/tr>\n
19<\/td>\n201.5 General requirements for testing me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
201.7. 2 Marking on the outside of me equipment or me equipment parts
201.7. 2.4 * Accessories
201.7. 2.101 Display of automated sphygmomanometers
201.7. 2.102 * Automated sphygmomanometer with neonatal mode
201.7. 2.103 * Automated sphygmomanometer intended for self-use in public areas <\/td>\n<\/tr>\n
20<\/td>\n201.7. 2.104 * Component replacement
201.7. 2.105 Disposal
201.7. 9.2 Instructions for use
201.7. 9.2.1 General <\/td>\n<\/tr>\n
21<\/td>\n201.7. 9.2.2 Warning and safety notices
201.7. 9.2.5 Me equipment description
201.7. 9.2.9 Operating instructions <\/td>\n<\/tr>\n
22<\/td>\n201.7. 9.2.13 * Maintenance
201.7. 9.2.101 Compatibility with hf surgical equipment
201.7. 9.2.102 Automated sphygmomanometers for use in neonatal mode
201.8 Protection against electrical hazards from me equipment <\/td>\n<\/tr>\n
23<\/td>\n201.8. 5.5 Defibrillation-proof applied parts
201.8. 5.5.101 * Patient connections of automated sphygmomanometers
201.9 Protection against mechanical hazards of me equipment and me systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11. 8 Interruption of the power supply\/supply mains to me equipment
201.11. 8.101 * Switching off
Table 201.102 \u2013 CUFF deflation pressure
201.11. 8.102 Interruption of the supply mains <\/td>\n<\/tr>\n
24<\/td>\n201.11. 8.103 * Internal electrical power source
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1 Accuracy of controls and instruments
201.12. 1.101 Measuring and display ranges <\/td>\n<\/tr>\n
25<\/td>\n201.12. 1.102 Limits of the error of the manometer from environmental conditions
201.12. 1.103 * Nominal blood pressure indication range
201.12. 1.104 Maximum pressure in normal condition
201.12. 1.105 * Maximum pressure in single fault condition <\/td>\n<\/tr>\n
26<\/td>\nFigure 201.101 \u2013 CUFF pressure PROTECTION DEVICE, triggered by overpressure in SINGLE FAULT CONDITION
201.12. 1.106 * Manometer test mode <\/td>\n<\/tr>\n
27<\/td>\nFigure 201.102 \u2013 CUFF pressure PROTECTION DEVICE, triggered by prolonged overpressure in SINGLE FAULT CONDITION
201.12. 1.107 * Reproducibility of the blood pressure determination <\/td>\n<\/tr>\n
28<\/td>\n201.12. 3 Alarm systems
201.12. 3.101 Additional alarm system requirements
201.13 Hazardous situations and fault conditions for me equipment <\/td>\n<\/tr>\n
29<\/td>\n201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15. 3.5 Rough handling test
201.15. 3.5.101 * Shock and vibration (robustness) <\/td>\n<\/tr>\n
30<\/td>\n201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
201.101 Requirements for cuffs
201.101. 1 * Construction
201.101. 2 * Pressurization
201.101. 3 * Automated sphygmomanometer intended for self-use in public areas with a single cuff size <\/td>\n<\/tr>\n
31<\/td>\n201.102 * Connection tubing and cuff connectors
201.103 Unauthorized access
201.104 * Maximum inflating time
Table 201.103 \u2013 CUFF inflation pressure <\/td>\n<\/tr>\n
32<\/td>\nFigure 201.103 \u2013 CUFF pressure and maximum inflation time, NORMAL CONDITION and SINGLE FAULT CONDITION
201.105 * Automatic cycling modes
201.105. 1 Long-term automatic mode <\/td>\n<\/tr>\n
33<\/td>\nFigure 201.104 \u2013 LONG-TERM AUTOMATIC MODE CUFF pressure in NORMAL CONDITION
Figure 201.105 \u2013 LONG-TERM AUTOMATIC MODE CUFF pressure in SINGLE FAULT CONDITION <\/td>\n<\/tr>\n
34<\/td>\n201.105. 2 * Short-term automatic mode
Figure 201.106 \u2013 SHORT-TERM AUTOMATIC MODE CUFF pressure
201.105. 3 * Self-measurement automatic mode
201.105. 3.1 General <\/td>\n<\/tr>\n
35<\/td>\nFigure 201.107 \u2013 SELF-MEASUREMENT AUTOMATIC MODE CUFF pressure <\/td>\n<\/tr>\n
36<\/td>\n201.105. 3.2 Normal condition
201.105. 3.3 * Single fault condition
201.106 * Clinical accuracy
202 Electromagnetic disturbances \u2013 Requirements and tests
202.4.3.1 Configurations
202.5.2.2.1 Requirements applicable to all me equipment and me systems <\/td>\n<\/tr>\n
37<\/td>\n202.8 Electromagnetic immunity requirements for me equipment and me systems
202.8.1 General
202.8.1.101 Additional general requirements
202.8.101 * Electrosurgery interference recovery <\/td>\n<\/tr>\n
38<\/td>\nFigure 202.101 \u2013 HF SURGICAL EQUIPMENT test layout <\/td>\n<\/tr>\n
39<\/td>\nFigure 202.102 \u2013 Simulated PATIENT test set-up for HF SURGICAL EQUIPMENT
206 Usability <\/td>\n<\/tr>\n
40<\/td>\n210 Requirements for the development of physiologic closed-loop controllers
210.4\u2003General requirements
211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
211.4.2.2\u2003Environmental conditions of transport and storage between uses
211.4.2.3.1\u2003Continous operating conditions
211.7.4.5\u2003Additional requirements for operating instructions
211.8.3.1\u2003Ingress of water or particulate matter into me equipment
212 Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment <\/td>\n<\/tr>\n
41<\/td>\n212.10.1.1\u2003General requirements for mechanical strength <\/td>\n<\/tr>\n
42<\/td>\nAnnexes <\/td>\n<\/tr>\n
43<\/td>\nAnnex C (informative) Guide to marking and labelling requirements for me equipment and me systems
201.C.1 Marking on the outside of me equipment, me systems or their parts
Table 201.C.101 \u2013 Marking on the outside of AUTOMATED SPHYGMOMANOMETERS or their parts
201.C.3 Marking of controls and instruments <\/td>\n<\/tr>\n
44<\/td>\nTable 201.C.102 \u2013 Marking of controls and instruments of AUTOMATED SPHYGMOMANOMETERS or their parts
201.C.4 Accompanying documents, general
Table 201.C.103 \u2013 ACCOMPANYING DOCUMENTS, general information for AUTOMATED SPHYGMOMANOMETERS
201.C.5 Accompanying documents, Instructions for use
Table 201.C.104 \u2013 ACCOMPANYING DOCUMENTS, instructions for use of AUTOMATED SPHYGMOMANOMETERS <\/td>\n<\/tr>\n
46<\/td>\n201.C.6 Accompanying documents, technical description
Table 201.C.105 \u2013 ACCOMPANYING DOCUMENTS, technical description of AUTOMATED SPHYGMOMANOMETERS <\/td>\n<\/tr>\n
47<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1\u2003General guidance
AA.2\u2003Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
53<\/td>\nTable AA.1 \u2013 Summary of requirements by mode <\/td>\n<\/tr>\n
55<\/td>\nAnnex BB (informative) Environmental aspects
Table BB.1 \u2013 Environmental aspects addressed by clauses of this document <\/td>\n<\/tr>\n
56<\/td>\nAnnex CC (informative) Reference to the essential principles
Table CC.1 \u2013 Correspondence between this particular standard and the ESSENTIAL PRINCIPLES <\/td>\n<\/tr>\n
59<\/td>\nBibliography <\/td>\n<\/tr>\n
61<\/td>\nIndex of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 80601-2-30:2018 – Medical electrical equipment-Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2018<\/td>\n62<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198232,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198229","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\/198229","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\/198232"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198229"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198229"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198229"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}