{"id":198403,"date":"2024-10-19T12:37:48","date_gmt":"2024-10-19T12:37:48","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80601-2-58-2014\/"},"modified":"2024-10-25T05:10:51","modified_gmt":"2024-10-25T05:10:51","slug":"aami-80601-2-58-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80601-2-58-2014\/","title":{"rendered":"AAMI 80601 2 58 2014"},"content":{"rendered":"

The purpose of this standard is to set appropriate requirements for the safety and performance of lens removal and vitrectomy devices for ophthalmic surgery to reduce the risk of detrimental impact on the medical treatment to an acceptable level for their intended use. The benefit of this standard is to the medical industry, manufacturers, medical regulators, hospitals, clinics, medical users and finally to the patient<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/
\nIEC 80601-2-58:2014, Medical electrical equipment \u2013 Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of IEC 80601-2-58:2014 <\/td>\n<\/tr>\n
9<\/td>\nFOREWORD <\/td>\n<\/tr>\n
11<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
13<\/td>\n201.1 Scope, object and related standards
201.1.1 * Scope
201.1.2 Object
201.1.3 Collateral standards
201.1.4 Particular standards <\/td>\n<\/tr>\n
14<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
15<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n201.4 General requirements
201.4.3 * Essential performance
201.4.3.101 General
201.4.101 * Additional functions
201.5 General requirements for testing of ME equipment
201.6 Classification of ME equipment and ME systems
201.7 ME equipment identification, marking and documents <\/td>\n<\/tr>\n
18<\/td>\n201.7.9.2.2 Warning and safety notices
201.7.9.2.8 Start-up procedure
201.7.9.2.9 Operating instructions
201.7.9.2.12 Cleaning, disinfection, and sterilization <\/td>\n<\/tr>\n
19<\/td>\n201.7.9.2.13 Maintenance
201.8 Protection against electrical hazards from ME equipment
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
201.11.1.2 Temperature of applied parts
201.11.1.2.1 Applied parts intended to supply heat to a patient
201.11.6.7 Sterilization of me equipment and me systems
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.1 Accuracy of controls and instruments <\/td>\n<\/tr>\n
20<\/td>\n201.12.1.101 Additional accuracy of controls and instruments requirements
201.12.1.101.1 Accuracy of static irrigation pressure <\/td>\n<\/tr>\n
21<\/td>\n201.12.1.101.2 Accuracy of aspiration pressure <\/td>\n<\/tr>\n
23<\/td>\n201.12.1.101.3 Accuracy of diathermy power
201.12.1.101.4 Accuracy of diathermy frequency
201.12.1.101.5 Accuracy of illumination output
201.12.1.101.6 * Fragmentation
201.12.1.101.7 Accuracy of ultrasonic velocity of tip <\/td>\n<\/tr>\n
25<\/td>\n201.12.1.101.8 Accuracy of velocity of fluid entering eye for liquefaction <\/td>\n<\/tr>\n
26<\/td>\n201.12.1.101.9 Accuracy of vitrectomy probe cut rate
201.12.4 Protection against hazardous output <\/td>\n<\/tr>\n
27<\/td>\n201.12.4.101.1 Hazardous output for static irrigation pressure
201.12.4.101.2 Hazardous output for aspiration
201.12.4.101.3 Hazardous output for diathermy power
201.12.4.101.4 Hazardous output for diathermy frequency
201.12.4.101.5 * Hazardous output for Illumination <\/td>\n<\/tr>\n
28<\/td>\n201.12.4.101.6 Fragmentation
201.12.4.101.7 Hazardous output for ultrasonic velocity of tip
201.12.4.101.8 Hazardous output for velocity of fluid entering eye for liquefaction
201.12.4.101.9 Hazardous output for vitrectomy probe cut rate
201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment
201.16 * ME systems
201.17 Electromagnetic compatibility of ME equipment and ME systems
202 Electromagnetic compatibility \u2013 Requirements and tests <\/td>\n<\/tr>\n
29<\/td>\n202.5.2.2.2 Requirements applicable to ME equipment and ME systems other than those specified for use only in a shielded location
202.5.2.2.3 * Requirements applicable to ME equipment and ME systems for use only in a shielded location <\/td>\n<\/tr>\n
30<\/td>\nAnnex C: Guide to marking and labelling requirements for me equipment and me systems
201.C.5 Accompanying documents, instructions for use <\/td>\n<\/tr>\n
31<\/td>\nAnnex AA: Particular guidance and rationale
A.A.1 General guidance
A.A.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
33<\/td>\nBibliography <\/td>\n<\/tr>\n
34<\/td>\nIndex of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 80601-2-58:2014 – Medical electrical equipment \u2013 Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n34<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198404,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198403","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\/198403","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\/198404"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198403"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198403"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}