{"id":198225,"date":"2024-10-19T12:37:08","date_gmt":"2024-10-19T12:37:08","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-2-2017\/"},"modified":"2024-10-25T05:10:17","modified_gmt":"2024-10-25T05:10:17","slug":"aami-60601-2-2-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-2-2017\/","title":{"rendered":"AAMI 60601 2 2 2017"},"content":{"rendered":"

Applies to medical electrical equipment which generates high frequency currents intended for the performance of surgical tasks and to surgical accessories intended to conduct, supplement or monitor high frequency energy applied to the patient from high frequency surgical equipment.<\/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\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\/IEC 60601-2-2:2017; Medical electrical equipment\u2014
\nPart 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
\n <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended 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 Page <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
7<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-2-2:2017 <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n201.1 Scope, object and related standards
201.1. 1\u2003* Scope
201.1. 2\u2003Object
201.1. 3\u2003Collateral standards
201.1. 4\u2003Particular standards <\/td>\n<\/tr>\n
12<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
13<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n201.4 General requirements <\/td>\n<\/tr>\n
17<\/td>\n201.4. 1.101\u2003* Additional conditions for application
201.4. 2.3.101\u2003* Evaluating risk
201.4. 3\u2003* Essential performance
201.4. 7\u2003Single fault condition for me equipment
201.4. 7.101\u2003Specific single fault conditions
201.4. 11\u2003Power input
201.5 General requirements for testing of me equipment
201.5. 4\u2003* Other conditions
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. 2.8.2\u2003Other power sources
201.7. 2.10\u2003Applied parts
201.7. 2.10.101\u2003* hf surgical accessories
201.7. 4.2\u2003* Control devices
201.7. 8.1\u2003* Colours of indicator lights <\/td>\n<\/tr>\n
19<\/td>\n201.7. 8.2\u2003* Colours of controls
201.7. 9.2.2\u2003Warning and safety notices
201.7. 9.2.2.101\u2003Additional information in instructions for use <\/td>\n<\/tr>\n
21<\/td>\n201.7. 9.2.14\u2003* Accessories, supplementary equipment, used material
201.7. 9.2.15\u2003Environmental protection <\/td>\n<\/tr>\n
22<\/td>\n201.7.9.3\u2003Technical description
201.7.9.3.1\u2003* General
201.8 Protection against electrical hazards from me equipment
201.8. 4\u2003Limitation of voltage, current or energy
201.8. 4.101\u2003* Neutral electrode monitoring circuit <\/td>\n<\/tr>\n
24<\/td>\n201.8. 4.102\u2003* Neuromuscular stimulation
201.8. 5.1.2\u2003* Means of patient protection (mopp)
201.8. 5.2.3\u2003* Patient leads or patient cables
201.8. 5.5\u2003* Defibrillation-proof applied parts
201.8. 6.1\u2003* Applicability of requirements <\/td>\n<\/tr>\n
25<\/td>\n201.8. 7.1\u2003* General requirements
201.8. 7.3\u2003* Allowable values
201.8. 7.3.101\u2003Thermal effects of hf leakage currents <\/td>\n<\/tr>\n
30<\/td>\n201.8. 8.2\u2003Distance through solid insulation or use of thin sheet material
201.8. 8.3\u2003Dielectric strength
201.8. 8.3.101 * Active accessory insulation
201.8. 8.3.102\u2003* Active accessory hf leakage <\/td>\n<\/tr>\n
32<\/td>\n201.8. 8.3.103\u2003* Active accessory hf dielectric strength <\/td>\n<\/tr>\n
33<\/td>\n201.8. 8.3.104\u2003* Active accessory mains frequency dielectric strength
201.8. 9.1.5\u2003Me equipment rated for high altitudes
201.8. 10.4 Cord-connected hand-held parts and cord-connected foot-operated control devices
201.8. 10.4.1\u2003Limitation of operating voltages
201.8. 10.4.2\u2003* Connection cords <\/td>\n<\/tr>\n
35<\/td>\n201.8. 10.4.101\u2003* Switch sensors
201.8. 10.4.101.1\u2003General
201.8. 10.4.101.2\u2003Non-continuous activation
201.8. 10.4.101.3\u2003Impedance sensing activation <\/td>\n<\/tr>\n
36<\/td>\n201.8. 10.4.101.4\u2003Footswitches
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. 1.1\u2003* Maximum temperature during normal use
201.11. 1.2.1\u2003Applied parts intended to supply heat to a patient
201.11. 1.2.2\u2003Applied parts not intended to supply heat to a patient
201.11. 6.3\u2003* Spillage on me equipment and me systems <\/td>\n<\/tr>\n
37<\/td>\n201.11. 6.5\u2003Ingress of water or particulate matter into me equipment and me systems
201.11. 6.7\u2003* Sterilization of me equipment and me systems
201.11. 8\u2003Interruption of the power supply \/ supply mains to me equipment
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12. 1\u2003Accuracy of controls and instruments <\/td>\n<\/tr>\n
38<\/td>\n201.12. 1.101\u2003Accuracy of output control setting
201.12. 1.102\u2003Monotonicity of output control setting <\/td>\n<\/tr>\n
40<\/td>\n201.12. 1.103\u2003* Accuracy of maximum output voltage
201.12. 2\u2003Usability of me equipment <\/td>\n<\/tr>\n
41<\/td>\n201.12. 4\u2003Protection against hazardous output
201.12. 4.101\u2003* Use of high current mode
201.12. 4.2\u2003* Indication relevant to safety
201.12. 4.2.101\u2003Output indicator <\/td>\n<\/tr>\n
42<\/td>\n201.12. 4.3\u2003Accidental selection of excessive output values
201.12. 4.3.101\u2003* Output reduction means
201.12. 4.4\u2003Incorrect output
201.12. 4.4.101\u2003* Maximum allowed output power in single fault conditions
201.12. 4.4.102\u2003* Output power during simultaneous activation <\/td>\n<\/tr>\n
43<\/td>\n201.13 Hazardous situations and fault conditions for me equipment
201.13. 2.13\u2003Overload
201.13. 2.13.101\u2003* Protection against the effects of short-circuiting of the electrodes <\/td>\n<\/tr>\n
44<\/td>\n201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15. 4.1\u2003Construction of connectors
201.15. 4.1.101\u2003* Compatibility with third party active electrodes
201.15. 4.1.102\u2003* Retention of detachable active electrodes
201.15. 101\u2003* Neutral electrodes
201.15. 101.1\u2003General requirements for neutral electrodes
201.15. 101.2\u2003* Ne cord attachment <\/td>\n<\/tr>\n
45<\/td>\n201.15. 101.3\u2003* Ne cord connector
201.15. 101.4\u2003* Ne cord insulation
201.15. 101.5\u2003* Ne thermal performance <\/td>\n<\/tr>\n
46<\/td>\n201.15. 101.6\u2003* Ne contact impedance <\/td>\n<\/tr>\n
47<\/td>\n201.15. 101.7\u2003* NE adhesion
201.15. 101.8\u2003* Ne shelf life <\/td>\n<\/tr>\n
48<\/td>\n201.15. 101.9\u2003* Adult neutral electrodes for conventional procedures
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
202 * Electromagnetic disturbances \u2013 Requirements and tests
202.2\u2003Normative references
202.3\u2003Terms and definitions
202.5.2.2.4\u2003Requirements applicable to me equipment that includes RF transmitters
202.5.2.2.6 Requirements applicable to me equipment and me systems that claim compatibility with hf surgical equipment
202.7\u2003electromagnetic emissions requirements for me equipment and me systems
202.7.1.2\u2003Operating modes <\/td>\n<\/tr>\n
49<\/td>\n202.8\u2003Electromagnetic immunity requirements for me equipment and me systems
202.8.1\u2003General
202.101\u2003Index of defined terms
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems <\/td>\n<\/tr>\n
50<\/td>\nAnnexes <\/td>\n<\/tr>\n
51<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
74<\/td>\nAnnex BB (informative) Electromagnetic disturbances created by hf surgical equipment
BB.1 Overview
BB.2 Terms and definitions
BB.3 Technical information
BB.3.1 General information about hf surgical equipment <\/td>\n<\/tr>\n
75<\/td>\nBB.3.2 Types of emissions created by hf surgical equipment
BB.3.2.1 Radiated
BB.3.2.2 Conducted through the mains power supply cord
BB.3.2.3 Conducted through the patient
BB.3.3 Measurement techniques <\/td>\n<\/tr>\n
76<\/td>\nBB.3.3.1 E-field measurements <\/td>\n<\/tr>\n
77<\/td>\nBB.3.3.2 H-field measurements
BB.3.3.3 Mains conducted measurements <\/td>\n<\/tr>\n
78<\/td>\nBB.3.4 Data summary
BB.3.4.1 E-field emissions
BB.3.4.2 H-field emissions
BB.3.4.3 Mains conducted emissions
BB.3.4.4 Maximum emission levels of hf surgical equipment <\/td>\n<\/tr>\n
79<\/td>\nBB.4 Suggested tests
BB.4.1
BB.4.2 <\/td>\n<\/tr>\n
80<\/td>\nBB.4.3
BB.4.4 <\/td>\n<\/tr>\n
81<\/td>\nBB.4.5
BB.4.6 <\/td>\n<\/tr>\n
82<\/td>\n201.18 Bibliography <\/td>\n<\/tr>\n
83<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 60601-2-2:2017 – Medical electrical equipment-Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2017<\/td>\n84<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198228,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198225","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\/198225","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\/198228"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198225"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198225"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}