{"id":371944,"date":"2024-10-20T02:27:01","date_gmt":"2024-10-20T02:27:01","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80601-2-852021\/"},"modified":"2024-10-26T04:15:59","modified_gmt":"2024-10-26T04:15:59","slug":"bs-en-iso-80601-2-852021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80601-2-852021\/","title":{"rendered":"BS EN ISO 80601-2-85:2021"},"content":{"rendered":"

Clause 1 of the general standard applies, except as follows.<\/p>\n

\n

NOTE The general standard is IEC 60601\u20111:2005+AMD1:2012+AMD2:2020.<\/p>\n<\/blockquote>\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\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
2<\/td>\nundefined <\/td>\n<\/tr>\n
5<\/td>\nContents Page <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n201.1 Scope, object and related standards
201.1.1 * Scope <\/td>\n<\/tr>\n
12<\/td>\n201.1.2 Object
201.1.3 Collateral standards <\/td>\n<\/tr>\n
13<\/td>\n201.1.4 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
20<\/td>\n201.4 General requirements <\/td>\n<\/tr>\n
21<\/td>\n201.4.3.101 * Additional requirements for essential performance
201.4.102 Additional requirements for acceptance criteria
201.4.103 Additional requirements for cerebral tissue oximeter equipment, parts and accessories <\/td>\n<\/tr>\n
22<\/td>\n201.5 General requirements for testing of ME equipment
201.6 Classification of ME equipment and ME systems
201.7 ME equipment identification, marking and documents
201.7.1.101 Information to be supplied by the manufacturer
201.7.2.3 Consult accompanying documents
201.7.2.9.101 IP classification <\/td>\n<\/tr>\n
23<\/td>\n201.7.2.101 Additional requirements for marking on the outside of ME equipment parts
201.7.4.3 Units of measurement
201.7.9.2 Instructions for use
201.7.9.2.1.101 Additional general requirements <\/td>\n<\/tr>\n
25<\/td>\n201.7.9.2.2.101 Additional requirements for warnings and safety notices
201.7.9.2.9.101 Additional requirements for operating instructions
201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment, used material <\/td>\n<\/tr>\n
26<\/td>\n201.7.9.3.1.101 * Additional general requirements
201.8 Protection against electrical hazards from ME equipment
201.8.3.101 Additional requirements for classification of applied parts
201.8.5.5.1.101 Defibrillation protection
201.8.7.4.7.101 Additional requirements for measurement of the patient leakage current <\/td>\n<\/tr>\n
27<\/td>\n201.9 Protection against mechanical hazards of ME equipment and ME systems
201.10 Protection against unwanted and excessive radiation hazards
201.10.4 Lasers
201.11 Protection against excessive temperatures and other hazards
201.11.1.2.2 Applied parts not intended to supply heat to a patient <\/td>\n<\/tr>\n
28<\/td>\n201.11.6.5.101 * Additional requirements for ingress of water or particulate matter into the ME equipment or ME system
201.11.6.7 Sterilization of ME equipment or ME system
201.11.8.101 Additional requirements for interruption of the power supply\/supply mains to ME equipment
201.11.8.101.1 Technical alarm condition for power supply failure <\/td>\n<\/tr>\n
29<\/td>\n201.11.8.101.2 Settings and data storage following short interruptions or automatic switchover
201.11.8.101.3 Operation following long interruptions
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.12.1.101 * StO2 accuracy of cerebral tissue oximeter equipment
201.12.1.101.1 * Specification <\/td>\n<\/tr>\n
31<\/td>\n201.12.1.101.2 * Data collection for determination of StO2 accuracy <\/td>\n<\/tr>\n
32<\/td>\n201.12.1.101.3 * Data analysis for determination of StO2 accuracy <\/td>\n<\/tr>\n
33<\/td>\n201.12.1.101.4 Characteristics of the study used for determination of StO2 accuracy
201.12.4 Protection against hazardous output
201.12.4.101 * Data update period
201.12.4.102 * Signal inadequacy <\/td>\n<\/tr>\n
34<\/td>\n201.13 Hazardous situations and fault conditions for ME equipment
201.13.101 Detection of probe faults and probe cable extender faults
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME equipment <\/td>\n<\/tr>\n
35<\/td>\n201.15.3.5.101 * Additional requirements for rough handling
201.15.3.5.101.1 * Shock and vibration (robustness) <\/td>\n<\/tr>\n
36<\/td>\n201.15.3.5.101.2 * Shock and vibration for a transit-operable cerebral tissue oximeter during operation <\/td>\n<\/tr>\n
37<\/td>\n201.15.101 Mode of operation
201.16 ME systems
201.17 Electromagnetic compatibility of ME equipment and ME systems
201.101 * Cerebral tissue oximeter probes and probe cable extenders
201.101.1 General <\/td>\n<\/tr>\n
38<\/td>\n201.101.2 Labelling
201.102 Functional connection
201.102.1 General
201.102.2 * Connection to an electronic health record or integrated clinical environment
201.102.3 Connection to a distributed alarm system <\/td>\n<\/tr>\n
39<\/td>\n202 Electromagnetic disturbances \u2014 Requirements and tests
202.4.3.1 Configurations
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems
202.8.1.101 Additional general requirements
202.8.2 Patient physiological simulation <\/td>\n<\/tr>\n
40<\/td>\n206 Usability
208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
208.6.1.2.101 * Additional requirements for alarm condition priority <\/td>\n<\/tr>\n
41<\/td>\n208.6.5.4.101 * Additional requirements for default alarm preset
208.6.8.5.101 Additional requirements for alarm signal inactivation states, indication and access
211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
212 Requirements for medical electrical equipment and medical electrical systems used in the emergency medical services environment <\/td>\n<\/tr>\n
42<\/td>\nAnnex C (informative) Guide to marking and labelling requirements for ME equipment and ME systems
201.C.1 Marking on the outside of ME equipment, ME systems or their parts
201.C.2 Accompanying documents, general <\/td>\n<\/tr>\n
43<\/td>\n201.C.3 Accompanying documents, instructions for use <\/td>\n<\/tr>\n
45<\/td>\n201.C.4 Accompanying documents, technical description <\/td>\n<\/tr>\n
46<\/td>\nAnnex D (informative) Symbols on marking <\/td>\n<\/tr>\n
47<\/td>\nAnnex AA (informative) Particular guidance and rationale
AA.1 General guidance <\/td>\n<\/tr>\n
49<\/td>\nAA.2 Rationale for particular clauses and subclauses <\/td>\n<\/tr>\n
58<\/td>\nAnnex BB (informative) Skin temperature at the cerebral tissue oximeter probe
BB.1 Surface temperature limits
BB.2 Literature review
BB.3 Test methods <\/td>\n<\/tr>\n
60<\/td>\nAnnex CC (informative) Determination of accuracy
CC.1 General
CC.2 Accuracy, bias and precision
CC.2.1 Definitions from other standards
CC.2.1.1 Accuracy
CC.2.1.2 Bias <\/td>\n<\/tr>\n
61<\/td>\nCC.2.1.3 Precision
CC.2.2 Effects of offset and linearity errors
CC.2.3 Bias (see Figures CC.1 and CC.2) <\/td>\n<\/tr>\n
63<\/td>\nCC.2.4 Precision
CC.2.5 Accuracy <\/td>\n<\/tr>\n
64<\/td>\nCC.2.6 Analysis <\/td>\n<\/tr>\n
65<\/td>\nCC.2.7 Trend accuracy
CC.2.8 Statistical Considerations <\/td>\n<\/tr>\n
66<\/td>\nAnnex DD (informative) Characteristics of a tissue haemoglobin phantom for the verification of the accuracy of cerebral tissue oximeter equipment
DD.1 General <\/td>\n<\/tr>\n
67<\/td>\nDD.2 Features of the tissue haemoglobin phantom
DD.2.1 General <\/td>\n<\/tr>\n
68<\/td>\nDD.2.2 Safety precautions regarding blood or blood components
DD.2.3 Composition of the tissue haemoglobin phantom liquid <\/td>\n<\/tr>\n
69<\/td>\nDD.2.4 Design of the tissue haemoglobin phantom setup
DD.2.4.1 Liquid-probe interface
DD.2.4.2 Container <\/td>\n<\/tr>\n
70<\/td>\nDD.2.4.3 Probe arrangement
DD.2.4.3.1 Immersed probe
DD.2.4.3.2 Probe attached to turbid window <\/td>\n<\/tr>\n
71<\/td>\nDD.2.5 Methods to change oxygenation <\/td>\n<\/tr>\n
72<\/td>\nDD.2.6 Reference measurement for SphanO2 <\/td>\n<\/tr>\n
73<\/td>\nDD.3 Procedures for verification of cerebral tissue oximeter equipment with the tissue haemoglobin phantom
DD.3.1 Purpose of the verification
DD.3.2 Test procedure of the verification <\/td>\n<\/tr>\n
74<\/td>\nDD.4 Specifications of the tissue haemoglobin phantom
DD.4.1 Target parameters of the tissue haemoglobin phantom <\/td>\n<\/tr>\n
75<\/td>\nDD.4.2 Properties of the tissue haemoglobin phantom to be disclosed <\/td>\n<\/tr>\n
76<\/td>\nAnnex EE (informative) Guideline for evaluating and documenting StO2 accuracy in human subjects
EE.1 General
EE.2 Procedure for laboratory testing on healthy volunteers
EE.2.1 Purpose of a controlled desaturation study
EE.2.2 Scope of a controlled desaturation study <\/td>\n<\/tr>\n
77<\/td>\nEE.2.3 Methods
EE.2.3.1 Study population <\/td>\n<\/tr>\n
78<\/td>\nEE.2.3.2 Apparatus
EE.2.3.2.1 CO-oximeter for measuring SaO2, SjvO2 and procedures and supplies recommended by the CO-oximeter manufacturer.
EE.2.3.2.2 Materials for arterial catheterization, jugular venous bulb catheter and blood sampling.
EE.2.3.2.3 Means for recording StO2 values (device under test), which can be manual or automated.
EE.2.3.2.4 Cerebral tissue oximeter equipment to be tested. See also EE.2.3.4 c).
EE.2.3.2.5 Means for delivering a medical grade oxygen-nitrogen mixture of varying FiO2 levels to the subject (e.g. pre-mixed high-pressure cylinders or gas-mixing equipment).
EE.2.3.3 Procedure <\/td>\n<\/tr>\n
80<\/td>\nEE.2.3.4 Data analysis
EE.3 Testing on patients
EE.3.1 Procedure <\/td>\n<\/tr>\n
82<\/td>\nAnnex FF (informative) Functional testers for cerebral tissue oximeter equipment
FF.1 General
FF.2 What is a simulator?
FF.3 What is a functional tester? <\/td>\n<\/tr>\n
83<\/td>\nFF.4 Types of functional testers and their uses <\/td>\n<\/tr>\n
85<\/td>\nAnnex GG (informative) Concepts of ME equipment response time
GG.1 General
GG.2 Fidelity <\/td>\n<\/tr>\n
87<\/td>\nGG.3 Effects of delays <\/td>\n<\/tr>\n
90<\/td>\nAnnex HH (normative) Data interface requirements
HH.1 Background and purpose
HH.2 Data definition <\/td>\n<\/tr>\n
93<\/td>\nHH.3 Clinical context <\/td>\n<\/tr>\n
94<\/td>\nAnnex II (informative) Comparison of methods of performance evaluation
II.1 General
II.2 Rationale for multiple methods of accuracy performance verification
II.3 Desire for improvement of methods for accuracy performance verification <\/td>\n<\/tr>\n
95<\/td>\nII.4 Optimizing the methods of accuracy performance verification
II.5 Comparing the methods of accuracy performance verification <\/td>\n<\/tr>\n
99<\/td>\nAnnex JJ (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n
102<\/td>\nAnnex KK (informative) Reference to the essential principles <\/td>\n<\/tr>\n
105<\/td>\nAnnex LL (informative) Reference to the general safety and performance requirements <\/td>\n<\/tr>\n
108<\/td>\nAnnex MM (informative) Terminology \u2014 alphabetized index of defined terms <\/td>\n<\/tr>\n
112<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n118<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":371952,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-371944","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/371944","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\/371952"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=371944"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=371944"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=371944"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}