{"id":198372,"date":"2024-10-19T12:37:42","date_gmt":"2024-10-19T12:37:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir62348-2012\/"},"modified":"2024-10-25T05:10:45","modified_gmt":"2024-10-25T05:10:45","slug":"aami-tir62348-2012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir62348-2012\/","title":{"rendered":"AAMI TIR62348 2012"},"content":{"rendered":"

The second edition of this technical report was prepared by the Secretariat of IEC\/SC 62A to summarize those changes cited in Amendment 1 that were assessed during the development process as having a moderate to significant impact on users of IEC 60601-1. The tables from the first edition of this technical report were retained in the second edition because there are counties that have not fully transitioned to the third edition of IEC 60601-1. Therefore, the original contents of IEC\/TR 62348 remain useful in those countries.<\/p>\n

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1<\/td>\nANSI\/AAMI\/IEC TIR 62348:2012, Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-5:2005 and mapping of the clauses of IEC 60601-5:2005 to the previous edition
\n <\/td>\n<\/tr>\n
3<\/td>\nTitle page
\n <\/td>\n<\/tr>\n
4<\/td>\nCopyright information
\n <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report
\n
ANSI Technical Report
\n <\/td>\n<\/tr>\n
6<\/td>\nContents
\n <\/td>\n<\/tr>\n
10<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
13<\/td>\nCommittee representation
\n <\/td>\n<\/tr>\n
15<\/td>\nBackground of ANSI\/AAMI adoption of IEC\/TR 62348:2012 <\/td>\n<\/tr>\n
16<\/td>\nForeword
\n <\/td>\n<\/tr>\n
18<\/td>\nIntroduction
\n <\/td>\n<\/tr>\n
19<\/td>\n1 Scope
\n
2 Normative references
3 Terms and definitions
4 Assessment of the changes in Amendment 1:2012 <\/td>\n<\/tr>\n
23<\/td>\n5 Changes impacting many users of the standard
5.1 Updated normative references (Clause 2) [Moderate impact]
5.2 Definition and rationale for expected service life (Definition 3.28 and rationale for 4.4) [Moderate impact]
5.3 Restructuring of risk management (Subclause 4.2) [Significant impact]
5.4 Application of essential performance (Subclause 4.3) [Significant impact] <\/td>\n<\/tr>\n
24<\/td>\n5.5 Revision to the concept of equivalent safety (Subclause 4.5) [Significant impact]
5.6 Requirements for parts that contact the patient (Subclause 4.6) [Significant impact]
5.7 Steady-state measurement of input of the ME equipment or ME system (Subclause 4.11) [Moderate impact]
5.8 Simultaneous fault testing (Subclause 5.1) [Moderate impact] <\/td>\n<\/tr>\n
25<\/td>\n5.9 Supply mains test characteristics (Subclause 5.5 a)) [Significant impact]
5.10 Humidity preconditioning (Subclause 5.7) [Significant impact]
5.11 Actuating mechanisms (Subclause 5.9.2.3) [Moderate impact]
5.12 Legibility of markings (Subclause 7.1.2) [Moderate impact]
5.13 Identification of ME
\n equipment, parts and accessories (Subclauses 7.2.1 and 7.2.4) [Significant impact]
5.14 Marking of fuses, thermal cut-outs and over-current releases (Subclause 7.3.4) [Moderate impact] <\/td>\n<\/tr>\n
26<\/td>\n5.15 Marking of stand-by control (Subclause 7.4.2) [Moderate impact]
5.16 Use of safety signs (Subclause 7.5) [Moderate impact]
5.17 General requirements for accompanying documents (Subclause 7.9.1) [Significant impact]
5.18 Disposal of waste (Subclause 7.9.2.15) [Moderate impact]
5.19 Unique version identification (Subclauses 7.9.2.19 and 7.9.3.1) [Moderate impact]
5.20 Disclosure of essential performance (Subclause 7.9.3.1) [Significant impact]
5.21 Change to the fundamental rule of protection against electric shock (Subclause 8.1 b)) [Moderate impact] <\/td>\n<\/tr>\n
27<\/td>\n5.22 Use of Y capacitors as a means of protection (Subclauses 8.5.1.2 and 8.5.1.3) [Moderate impact]
5.23 Requirements for impedance and current-carrying capabilities (Subclause 8.6.4) [Moderate impact]
5.24 Allowable values of leakage currents that can flow in a functional earth conductor (Subclause 8.7.3) [Substantial impact]
5.25 Measurement of the earth leakage current and current in functional earth connection (Subclause 8.7.4.5) [Moderate impact]
5.26 Clarification of the insulation to be tested (Subclause 8.8.1) [Significant impact]
5.27 Spacing for one means of operator protection for a working voltage of 25 V r.m.s. (Table 16) [Moderate impact] <\/td>\n<\/tr>\n
28<\/td>\n5.28 Measurement of creepage distances and air clearances (Subclause 8.9.4) [Moderate impact]
5.29 Spillage on ME equipment and ME
\n systems (Subclause 11.6.3) [Moderate impact]
5.30 Cleaning and disinfection of ME equipment and ME
\n systems (Subclause 11.6.6) [Moderate impact]
5.31 Interruption of the power supply \/ supply mains to ME equipment or ME
\n system (Subclauses 11.8 and 16.8) [Significant impact]
5.32 Emissions, deformation of enclosure or exceeding maximum temperature (Subclause 13.1.2) [Significant impact]
5.33 Programmable electrical medical systems (PEMS
\n) (Subclause 14.1) [Moderate impact] <\/td>\n<\/tr>\n
29<\/td>\n5.34 Design and implementation (Subclause 14.9) [Moderate impact]
5.35 PEMS
\n validation (Subclause 14.11) [Moderate impact]
5.36 Mechanical strength (Subclause 15.3.1) [Moderate impact]
5.37 Actuating parts of controls of ME
\n equipment (Subclause 15.4.6.1 b) [Moderate impact]
5.38 Limitation of movement (Subclause 15.4.6.2) [Moderate impact]
5.39 Transformers (Subclause 15.5.1.1) [Moderate impact]
5.40 Overload test (Subclause 15.5.1.3) [Moderate impact] <\/td>\n<\/tr>\n
30<\/td>\n5.41 Dielectric strength (Subclause 15.5.2) [Moderate impact]
5.42 Construction of transformers used to provide separation as required by 8.5 (Subclause 15.5.3) [Significant impact]
5.43 Resistors bridging a means of protection (Rationale for Subclause 4.8) [Moderate impact]
6 Changes impacting particular users of the standard
6.1 ME
\n equipment intended to receive power from other equipment (Subclause 7.2.5) [Significant impact]
6.2 ME
\n equipment or accessories supplied sterile (Subclauses 7.2.17 and 7.9.2.18) [Moderate impact] <\/td>\n<\/tr>\n
31<\/td>\n6.3 ME
\n equipment supplied from an external pressure source (Subclause 7.2.18) [Moderate impact]
6.4 Mass of mobile ME
\n equipment (Subclause 7.2.21) [Significant impact]
6.5 General requirements for the instructions for use when the patient is an operator (Subclause 7.9.2.1) [Moderate impact]
6.6 ME
\n equipment emitting radiation (Subclause 7.9.2.17) [Moderate impact]
6.7 ME
\n equipment with defibrillation-proof applied parts (Subclause 8.5.5.1 a)) [Significant impact] <\/td>\n<\/tr>\n
32<\/td>\n6.8 Energy reduction test for ME
\n equipment with defibrillation-proof applied parts (Subclause 8.5.5.2) [Significant impact]
6.9 Measurement of leakage current for sterile equipment (Subclause 8.7.1 b)) [Moderate impact]
6.10 Isolation of permanently installed ME
\n equipment from the supply mains (Subclause 8.11.1) [Moderate impact]
6.11 Protective measures (Subclause 9.2.2.4.4) [Moderate impact]
6.12 Continuous activation (Subclause 9.2.2.5) [Moderate impact]
6.13 Speed of movement(s) (Subclause 9.2.2.6) [Moderate impact]
6.14 Unintended movement (Subclause 9.2.3.1) [Significant impact]
6.15 Overtravel end stops (subclause 9.2.3.2) [Moderate impact] <\/td>\n<\/tr>\n
33<\/td>\n6.16 Overbalancing from horizontal and vertical forces (Subclause 9.4.2.3 a)) [Significant impact]
6.17 Movement over a threshold (Subclause 9.4.2.4.3) [Significant impact]
6.18 Instability of mobile ME
\n equipment in transport position (Subclause 9.4.3.1 c)) [Moderate impact]
6.19 Instability of mobile ME
\n equipment on an incline surface and in other than transport position (Subclause 9.4.3.2 a)) [Moderate impact]
6.20 Instability of mobile ME
\n equipment from lateral forces in other than transport position (Subclause 9.4.3.2 b)) [Significant impact]
6.21 Acoustic energy and vibration (Subclause 9.6.1) [Moderate impact]
6.22 Audible acoustic energy measurements (Subclause 9.6.2.1) [Moderate impact]
6.23 Static forces due to loading from persons (Subclause 9.8.3.2) [Moderate impact] <\/td>\n<\/tr>\n
34<\/td>\n6.24 Dynamic forces due to loading from persons (Subclause 9.8.3.3) [Moderate impact]
6.25 ME
\n equipment not intended to produce diagnostic or therapeutic X-radiation (Subclause 10.1.1) [Moderate impact]
6.26 ME
\n equipment intended to produce diagnostic or therapeutic X-radiation (Subclause 10.1.2) [Moderate impact]
6.27 Microwave radiation (Subclause 10.3) [Significant impact]
6.28 Lasers and light-emitting diodes (LEDs) (Subclause 10.4) [Moderate impact]
6.29 Applied parts not intended to supply heat to a patient (Subclause 11.1.2.2) [Moderate impact]
6.30 Overflow in ME
\n equipment (Subclause 11.6.2) [Moderate impact]
6.31 Diagnostic X-ray equipment (Subclause 12.4.5.2) [Moderate impact] <\/td>\n<\/tr>\n
35<\/td>\n6.32 PEMS
\n intended to be incorporated into an IT-network (Subclause 14.13) [Moderate impact]
6.33 Rough handling test (Subclause 15.3.5) [Moderate impact]
6.34 Application of temperature and overload control devices (Subclause 15.4.2.1 d)) [Moderate impact]
6.35 Excessive current and voltage protection (Subclause 15.4.3.5) [Moderate impact]
6.36 Entry of liquids for foot-operated control devices (Subclause 15.4.7.3) [Moderate impact]
6.37 ME
\n system power supply (Subclause 16.3) [Moderate impact]
6.38 General measurement conditions for ME
\n systems (Subclause 16.6.4.1) [Moderate impact] <\/td>\n<\/tr>\n
36<\/td>\n6.39 An MSO
\n combined with a separating transformer (Subclause 16.9.2.1 d)) [Moderate impact]
6.40 Impedance of protective earth connections in ME
\n systems (Subclause 16.9.2.2) [Moderate impact]
7 Mapping
7.1 Mapping to the second edition of IEC 60601-1 <\/td>\n<\/tr>\n
70<\/td>\n7.2 Mapping to the second edition of IEC 60601-1-1 <\/td>\n<\/tr>\n
72<\/td>\n7.3 Mapping to the first edition of IEC 60601-1-4, as amended <\/td>\n<\/tr>\n
76<\/td>\n7.4 Mapping from IEC 60601-1:2005 + A1:2012
\n <\/td>\n<\/tr>\n
112<\/td>\nBibliography
\n <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC TIR62348:2012 – Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2012<\/td>\n112<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198379,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198372","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\/198372","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\/198379"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198372"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198372"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198372"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}