{"id":197986,"date":"2024-10-19T12:36:19","date_gmt":"2024-10-19T12:36:19","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-80601-2-58-2014-a1-2016\/"},"modified":"2024-10-25T05:09:35","modified_gmt":"2024-10-25T05:09:35","slug":"aami-80601-2-58-2014-a1-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-80601-2-58-2014-a1-2016\/","title":{"rendered":"AAMI 80601 2 58 2014 A1 2016"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/IEC 80601-2-58:2014\/A1:2016; Amendment 1 to Medical electrical equipment\u2014Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
\n <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards andrecommended practices <\/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 Amendment 1 to IEC 80601-2-58:2014 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction to the Amendment
201.1.3\u2003Collateral standards
201.1.3\u2003* Collateral standards
201.1.4\u2003Particular standards
201.2\u2003Normative references <\/td>\n<\/tr>\n
12<\/td>\n201.7\u2003Me equipment identification, marking and documents
201.7.6.101\u2003* Additional symbols
201.7.9.2.12\u2003Cleaning, disinfection, and sterilization
201.11.6.7\u2003Sterilization of me equipment and me systems
201.12.1.101.7\u2003Accuracy of ultrasonic velocity of tip
201.12.1.101.8\u2003Accuracy of velocity of fluid entering eye for liquefaction <\/td>\n<\/tr>\n
13<\/td>\n201.13 Hazardous situations and fault conditions for ME EQUIPMENT
201.13\u2003Hazardous situations and fault conditions for me equipment
202\u2003Electromagnetic compatibility \u2013 Requirements and tests
202 \u2003Electromagnetic disturbances \u2013 Requirements and tests
202.5.2.2.2 * Requirements applicable to me equipment and me systems specified for use only in a shielded location special environment
202.5.2.2.4\u2003Requirements applicable to me equipment that includes RF transmitters
202.7\u2003Electromagnetic emissions requirements for me equipment and me systems
202.7.1.2\u2003Operating modes
202.8\u2003Electromagnetic immunity requirements for me equipment and me systems
202.8.1\u2003* General
Annexes <\/td>\n<\/tr>\n
14<\/td>\nAnnex D (informative) Symbols on marking (See Clause 7)
Table D.4 \u2013 LENS REMOVAL and VITRECTOMY symbols <\/td>\n<\/tr>\n
15<\/td>\nAnnex AA (informative) Particular guidance and rationale
A.A.2\u2003Rationale for particular clauses and subclauses
Subclause 201.1.3 \u2013 Collateral standards
Subclause 201.4.3 \u2013 Essential performance <\/td>\n<\/tr>\n
16<\/td>\nSubclause 201.4.101 \u2013 Additional functions
Subclause 201.7.6.101 \u2013 Additional symbols <\/td>\n<\/tr>\n
17<\/td>\nClause 201.16 \u2013 Me systems
Subclause 202.5.2.2.2 \u2013 Requirements applicable to me equipment and me systems specified for use only in a shielded location special environment
Subclause 202.8.1 \u2013 General <\/td>\n<\/tr>\n
18<\/td>\nBibliography <\/td>\n<\/tr>\n
19<\/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-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>\n19<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":197992,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-197986","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\/197986","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\/197992"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=197986"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=197986"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=197986"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}