{"id":198220,"date":"2024-10-19T12:37:07","date_gmt":"2024-10-19T12:37:07","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-16-2012\/"},"modified":"2024-10-25T05:10:16","modified_gmt":"2024-10-25T05:10:16","slug":"aami-60601-2-16-2012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-16-2012\/","title":{"rendered":"AAMI 60601 2 16 2012"},"content":{"rendered":"

Specifies the minimum safety requirements for single-patient hemodialysis, hemodiafiltration and hemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including hemodialysis, hemodiafiltration and hemofiltration equipment operated by 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\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 60601-2-16:2012, Medical electrical equipment \u2014 Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment <\/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 <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
10<\/td>\nCommittee representation <\/td>\n<\/tr>\n
12<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-2-16:2012 <\/td>\n<\/tr>\n
13<\/td>\nFOREWORD <\/td>\n<\/tr>\n
16<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
17<\/td>\n201.1 Scope, object and related standards
201.1. 1 Scope <\/td>\n<\/tr>\n
18<\/td>\n201.1. 2 Object
201.1. 3 Collateral standards
201.1. 4 Particular standards <\/td>\n<\/tr>\n
19<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
20<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
22<\/td>\n201.4 General requirements <\/td>\n<\/tr>\n
23<\/td>\n201.4. 3 * Essential performance
201.4. 3.101 * Additional essential performance requirements
201.4.3.102\u2003Blood flow
201.4.3.103\u2003Dialysis fluid flow <\/td>\n<\/tr>\n
24<\/td>\n201.4.3.104\u2003Net fluid removal
201.4.3.105\u2003Substitution fluid flow <\/td>\n<\/tr>\n
25<\/td>\n201.4.3.106 Dialysis time
201.4.3.107 * Dialysis fluid composition
201.4.3.108\u2003Dialysis fluid temperature <\/td>\n<\/tr>\n
26<\/td>\n201.4.3.109\u2003Substitution fluid temperature
201.4.7\u2003Single fault condition for ME equipment
201.5 General requirements for testing of me equipment <\/td>\n<\/tr>\n
27<\/td>\n201.6 Classification of me equipment and me systems
201.7 ME equipment identification, marking and documents
201.7.4.3 Units of measure
201.7.9.2 Instructions for use
201.7.9.2.2 Warning and safety notices <\/td>\n<\/tr>\n
28<\/td>\n201.7.9.2.5 ME equipment description <\/td>\n<\/tr>\n
29<\/td>\n201.7.9.2.6 Installation
201.7.9.2.12 Cleaning, disinfection and sterilization
201.7.9.2.14 Accessories, supplementary equipment, used material <\/td>\n<\/tr>\n
30<\/td>\n201.7.9.3\u2003 Technical description
201.7.9.3.1 General <\/td>\n<\/tr>\n
31<\/td>\n201.8 Protection against electrical hazards from ME equipment
201.8.3\u2003* Classification of applied parts
201.8.7.4.7 Measurement of the patient leakage current <\/td>\n<\/tr>\n
32<\/td>\n201.8.11.2 * Multiple socket-outlets
\n
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
201.11.6.3 Spillage on ME equipment and ME systems
201.11.6.6 *Cleaning and disinfection of ME equipment and ME systems
\n
201.11.8 *Interruption of the power supply \/ supply mains to ME equipment <\/td>\n<\/tr>\n
33<\/td>\n201.12 * Accuracy of controls and instruments and protection against hazardous outputs
201.12.4.4\u2003Incorrect output
201.12.4.4.101\u2003*Dialysis fluid composition <\/td>\n<\/tr>\n
35<\/td>\n201.12.4.4.102\u2003*Dialysis fluid and substitution fluid temperature
201.12.4.4.103\u2003*Net fluid removal <\/td>\n<\/tr>\n
36<\/td>\n201.12.4.4.104\u2003Extracorporeal blood loss
201.12.4.4.104.1 Extracorporeal blood loss to the environment <\/td>\n<\/tr>\n
37<\/td>\n201.12.4.4.104.2 *Blood leak to the dialysis fluid
\n
201.12.4.4.104.3 * Extracorporeal blood loss due to coagulation <\/td>\n<\/tr>\n
38<\/td>\n201.12.4.4.105 * Air infusion <\/td>\n<\/tr>\n
41<\/td>\n201.12.4.4.106 Alarm override modes <\/td>\n<\/tr>\n
42<\/td>\n201.12.4.4.107 Protective systems
201.12.4.4.108 Prevention of contamination by chemicals
201.12.4.4.109 *Blood pump(s) and\/or substitution pump(s) reversal <\/td>\n<\/tr>\n
43<\/td>\n201.12.4.4.110 Selection and change of operation modes
201.12.4.4.111 Online HDF and online
\n HF
201.13 Hazardous situations and fault conditions
201.13.2.6 * Leakage of liquid <\/td>\n<\/tr>\n
44<\/td>\n201.14 Programmable electrical medical systems (PEMS)
201.14.13\u2003*Connection of PEMS by network\/data coupling to other equipment
201.15 Construction of ME equipment
201.15.4.1\u2003Construction of connectors
201.15.4.1.101 * Dialysis fluid concentrate connectors <\/td>\n<\/tr>\n
45<\/td>\n201.15.4.1.102 *Connectors for blood pressure transducers
201.16 * ME systems
201.16.1 General requirements for the ME systems
\n
201.16.2\u2003Accompanying documents of an ME system
201.16.6.3\u2003Patient leakage current
201.16.9.1 * Connection terminals and connectors <\/td>\n<\/tr>\n
46<\/td>\n201.17 Electromagnetic compatibility of ME equipment and ME systems
202 Electromagnetic compatibility \u2013 Requirements and tests
202.3.18 Life-supporting ME equipment or ME system
\n
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.4 *General requirements <\/td>\n<\/tr>\n
47<\/td>\n208.5.2.1 Instructions for use
208.6.3\u2003Generation of alarm signals
208.6.3.1\u2003*General
208.6.3.3.2\u2003*Volume of auditory alarm signals and information signals
208.6.3.3.101 *Special characteristics of auditory alarm signals for hemodialysis equipment <\/td>\n<\/tr>\n
48<\/td>\n210 Process requirements for the development of physiologic closed-loop controllers
211 * Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Annexes (general)
\n <\/td>\n<\/tr>\n
49<\/td>\nAnnex G (normative) Protection against hazards
\n of ignition of flammable anesthetic mixtures <\/td>\n<\/tr>\n
50<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1 General guidance
AA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
70<\/td>\nAnnex BB (informative) Examples of hazards, foreseeable sequences of events, and hazardous situations in hemodialysis equipment <\/td>\n<\/tr>\n
78<\/td>\nBibliography <\/td>\n<\/tr>\n
79<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/IEC 60601-2-16:2012 – Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment<\/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>\n80<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198223,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198220","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\/198220","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\/198223"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198220"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198220"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198220"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}