您當(dāng)前的位置：檢測(cè)資訊 > 法規(guī)標(biāo)準(zhǔn)
嘉峪檢測(cè)網(wǎng) 2026-05-02 22:37
節(jié)前接到一個(gè)任務(wù)，需要看看監(jiān)護(hù)相關(guān)標(biāo)準(zhǔn)的國(guó)內(nèi)外的狀態(tài)和差異。那就本著假期在家陪中考的好大兒，閑著也閑著，看看這個(gè)假期能不能把標(biāo)準(zhǔn)差異都給做出來(lái)吧。
|
IEC/ISO 標(biāo)準(zhǔn)最新版本 |
國(guó)內(nèi)標(biāo)準(zhǔn) |
國(guó)內(nèi)標(biāo)準(zhǔn)對(duì)應(yīng)的國(guó)際標(biāo)準(zhǔn)版本 |
|
IEC 60601-1:2005 +A1:2012+A2:2020 |
GB 9706.1-2020 |
IEC 60601-1:2005 +A1:2012 |
|
IEC 60601-1-2:2014 +A1:2020 |
YY 9706.102-2021 |
IEC 60601-1-2:2007 |
|
IEC 60601-1-6:2010 +A1:2013+A2:2020 |
YY/T9706.106-2021 |
IEC 60601-1-6:2010 +A1:2013 |
|
IEC 60601-1-8:2006 +A1:2012+A2:2020 |
YY 9706.108-2021 |
IEC 60601-1-8:2006 +A1:2012 |
|
IEC 60601-2-10:2012 +A1:2016+A2:2023 |
YY 9706.210-2021 |
IEC 60601-2-10: 2012 +AMD1:2016 |
|
IEC 60601-2-25:2011 |
GB 9706.225-2021 |
IEC 60601-2-25:2011 |
|
IEC 80601-2-26:2019 +AMD1:2024 |
GB 9706.226-2021 |
IEC 60601-2-26:2012 |
|
IEC 60601-2-27: 2011 +C1: 2012 |
GB 9706.227-2021 |
IEC 60601-2-27: 2011+ C1: 2012 |
|
IEC 80601-2-30:2018 |
YY 9706.230-2023 |
IEC 80601-2-30:2018 |
|
IEC 60601-2-34:2024 |
YY 9706.234-2021 |
IEC 60601-2-34:2011 |
|
IEC 60601-2-40:2024 |
YY 9706.240-2021 |
IEC 60601-2-40:2016 |
|
IEC 80601-2-49:2018 +AMD1:2024 |
YY 9706.249-2023 |
IEC 80601-2-49:2018 |
|
ISO 80601-2-55:2018 +A1:2023 |
GB 9706.255-2022 |
ISO 80601-2-55:2018 |
|
ISO 80601-2-56:2017 +A1:2018 |
YY 9706.256-2023 |
ISO 80601-2-56:2017+A1:2018 |
|
ISO 80601-2-61:2026 |
YY 9706.261-2023 |
ISO 80601-2-61:2017+C1:2018 |
|
ISO 80601-2-85:2021 |
GB 9706.285-202X |
|
不整理不知道，一整理才發(fā)現(xiàn)其實(shí)很多適用的標(biāo)準(zhǔn)都存在著版本的差異，很多就差個(gè)修訂版本，譬如通用標(biāo)準(zhǔn)GB 9706.1, 報(bào)警YY 9706.108， 大的可能差了兩個(gè)版本， 譬如GB 9706.226-2021。當(dāng)然其中很多和IEC/ISO 標(biāo)準(zhǔn)版本一致的其實(shí)也是IEC/ISO 已經(jīng)有新的版本在起草或者準(zhǔn)備發(fā)布的過(guò)程中，譬如無(wú)創(chuàng)血壓IEC 80601-2-30, 神奇的心電標(biāo)準(zhǔn)IEC 80601-2-86, 體溫ISO 80601-2-56.
插播一個(gè)， 在差上面標(biāo)準(zhǔn)更新?tīng)顟B(tài)時(shí)，無(wú)意瞥見(jiàn)了無(wú)創(chuàng)血壓臨床的標(biāo)準(zhǔn)，知道ISO 81060-2:2024要升版，上次看還是CD，這么快就DIS了，更新真快。
回到主題，所以整體來(lái)講所有監(jiān)護(hù)相關(guān)的標(biāo)準(zhǔn)國(guó)內(nèi)外還是有很大差異的?；氐阶约?，真的也是懶了，要放以前差異評(píng)估早都做完了，現(xiàn)在翻翻，貌似只做了兩三個(gè)，好吧，看來(lái)這個(gè)勞動(dòng)節(jié)要好好勞動(dòng)了。之前關(guān)于有創(chuàng)血壓的標(biāo)準(zhǔn)已經(jīng)分享了差異有創(chuàng)血壓監(jiān)護(hù)設(shè)備IEC 標(biāo)準(zhǔn)更新今天來(lái)聊聊腦電的差異
|
<p class="MsoNormal" style="text-align: center; mso-element: frame; mso-element-frame-hspace: 9.0pt; mso-element-wrap: around; mso-element-anchor-vertical: <p> paragraph; mso-element-anchor-horizontal: column; mso-element-left: 6.85pt; mso-element-top: .05pt; mso-height-rule: exactly; font-size: 17px; font-weight: 400; color: rgba(0,0,0,0.9); line-height: 1.8; margin-bottom: 24px" en-us"="">Gap Type (“R =Revised,” “N = New”) |
Gap Content (“D = Deleted”, “E = Editorial,” “M = Mapped,” or “T = Technical”) |
|||||
|
IEC 80601-2-26:2019+A1:2024 |
GB 9706.226-2021 |
Gap Type |
Gap Content |
Requirement |
Analysis Comment
|
|
|
201.1.1 * Scope |
201.1.1 |
R |
T |
1. The scope include the ME and ME System, and extend the intended use for EMS and Home healthcare. 2. remove electroencephalographic telemetry and ambulatory electroencephalographic recorders from the scope. 3. Add an explanation and requirements about the ME which function is not completely integrated. |
Item 1 intended use include EMS and Home healthcare. |
|
|
201.1.3 Collateral standards |
201.1.3 |
R |
T |
Align to latest edition IEC 60601-1-2 and IEC60601-1-6. Exclude IEC60601-1-3, IEC60601-1-10 and IEC60601-1-9. |
Align to IEC 60601-1-2, IEC 60601-1-6. |
|
|
201.1.1.4 Particular standards |
201.1.1.4 |
R |
T |
Update the revision of: IEC 60601-1
|
Reference change, no impact on requirements. |
|
|
201.2 Normative references |
201.2 |
R |
T |
Update the revision of: IEC 60601-1-2, IEC 60601-1 Add IEC 60601-1-6, IEC 60601-1-11, IEC 60601-1-12 and IEC 60601-2-2. Remove IEC 60601-2-27 |
Reference change, no impact on requirements. |
|
|
201.3 Terms and definitions |
201.3 |
R |
T |
Add IEC60601-1, IEC 60601-1-2, IEC60601-1-6, IEC60601-1-11, IEC60601-1-12 and IEC 60601-2-2. Add ISO and IEC database address. |
No requirement changes. |
|
|
201.3.201 CHANNEL |
201.3.201 |
R |
T |
Change the lead to voltage between electrodes |
Correct the description of channel. |
|
|
201.3.202 ELECTRODE |
201.3.203 |
R |
T |
sensor that is applied to the scalp, cerebral cortex, or subdural locations to detect electrical activity of the brain |
Add the sensor location for application. |
|
|
201.3.203 ELECTROENCEPHALOGRAM EEG |
201.3.202 |
R |
E |
Subclause Number change |
Definition is same. |
|
|
N/A |
201.3.204 GAIN |
R |
D |
Remove the definition of Gain. |
Definition removed. |
|
|
N/A |
201.3.205 LEAD |
R |
D |
Remove the definition of Lead |
Definition removed. |
|
|
201.3.204 ELECTROENCEPHALOGRAPH |
201.3.63 MEDICAL ELECTRICAL EQUIPMENT |
R |
D |
Remove ELECTROENCEPHALOGRAPH ME EQUIPMENT device to produce an ELECTROENCEPHALOGRAM |
Combine it to 201.3.203. |
|
|
201.3.205 LEAD WIRE |
201.3.206 |
R |
E |
Subclause Number change |
Definition is same. |
|
|
201.3.206 NEUTRAL ELECTRODE |
201.3.207 |
R |
T |
reference point for differential amplifiers and/or interference suppression circuits |
Remove the information about “not intended to be used to calculate any LEAD” |
|
|
201.3.207 PATIENT CABLE |
201.3.208 |
R |
T |
multiwire cable or junction box used to connect LEAD WIRES to the ELECTROENCEPHALOGRAPH |
Add the junction box to the definition. |
|
|
201.4.3.101 Additional ESSENTIAL PERFORMANCE requirements |
201.4.3.101 |
R |
T |
The EP list is added one alternative requirement: 201.12.4.101 indication of invalid data and add additional requirement about the EP check on 10 channels when the device have more than 10 channels. |
Risk management process should consider the new added EP. |
|
|
201.5.4 Other conditions |
201.5.4 |
R |
D |
Remove the requirement about the accessories and recording materials. |
The other requirements about the test circuits and internal electrical power source ME have no changes. |
|
|
201.5.8 * Sequence of tests |
201.5.8 |
R |
E |
The EP related subclause number change. Requirements are same. |
The test sequence requirement is same. |
|
|
N/A |
201.6.2 Protection against electric shock |
R |
D |
Remove the classification of protection against electric shock: BF or CF. |
The APPLIED PARTS classification requirement is removed. |
|
|
201.7.9.2.2 Warning and safety notices |
201.7.9.2.101 g) |
R |
E |
Separated it from 201.7.9.2.101 |
Editorial change |
|
|
201.7.9.2.101 Additional instructions for use |
201.7.9.2.101 |
R |
T/D |
Modified items: a) Change the “brain death” to ‘electro-cerebral inactivity (ECI)’ i) Technical specifications for the ELECTROENCEPHALOGRAPH of sufficient detail to allow the OPERATOR to understand what is being measured and any limitations. Minimally this shall include: – accuracy of signal reproduction; – input dynamic range and maximum offset voltage; – noise; – frequency range and bandwidth; – common mode rejection – a description of all functions; – a description of waveform displays (if applicable).
Removed items: c) Instructions for connecting a POTENTIAL EQUALIZATION CONDUCTOR, if applicable. h) The choice and application of specified PATIENT CABLES and LEAD WIRES; the choice and application of ELECTRODES
New added items: k) If applicable, limitations of multipurpose CHANNELS (e.g. that these CHANNELS are not suitable for monitoring and of ECG or EMG) and to which clauses of applicable standards (e.g. IEC 80601-2-xx) they were tested, if any. |
The new added requirements in Item i) and k) should be added to IFU. |
|
|
201.8.1.101 * Multipurpose CHANNEL(S) |
201.8.101 |
R |
T |
The ACCOPANYING documents should include the applicable clauses of relevant standards if the channels are used other than EEG. |
New added requirement about the special use. |
|
|
201.8.5.2.3 * PATIENT leads or PATIENT cables |
201.8.5.2.3 |
R |
T |
Any detachable ELECTRODE connector of a LEAD WIRE shall, when separated from the ELECTRODE, have an air clearance between connector pins and a flat surface of at least 0,5 mm. |
Same as the requirement as ECG cable |
|
|
201.8.5.5.1 Defibrillation protection |
201.8.5.5.1 |
R |
T |
Common mode test: The 10HZ sine wave generator 0.25 mv P-to- V vs 0.5 in previous revision. The resistor of Figure 201.101 adds the 5kv dielectric strength capability. Differential mode test: The 10HZ sine wave generator 0.25 mv P-to- V vs 0.5 in previous revision. The resistor of Figure 201.102 adds the 5kv dielectric strength capability. And remove the test 20s interval of discharge. Energy reduction test The resistor of Figure 201.102 adds the 5kv dielectric strength capability. |
The test method was update. |
|
|
N/A |
201.11.6.3 *Spillage on ME EQUIPMENT and ME SYSTEMS |
R |
D |
Remove the Spillage testing |
Remove the spillage testing. |
|
|
201.11.8 * Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT |
201.11.8 |
R |
E |
Change the NOTE “Means may be provided to the OPERATOR to select one or more than one of the above options” to a requirement. |
Editorial change. No impact on the compliance. |
|
|
201.11.8.101 Protection against depletion of the INTERNAL ELECTRICAL POWER SOURCE |
N/A |
N |
T |
ELECTROENCEPHALOGRAPHS powered from an INTERNAL ELECTRICAL POWER SOURCE shall not cause a HAZARDOUS SITUATION to the PATIENT when the state of discharge can no longer maintain the NORMAL USE of the ELECTROENCEPHALOGRAPH (see 201.15.4.4.101): When the state of discharge of any INTERNAL ELECTRICAL POWER SOURCE is such that the ELECTROENCEPHALOGRAPH can no longer function in accordance with the MANUFACTURER’s specification, theELECTROENCEPHALOGRAPH shall power down in a manner which causes no HAZARDOUS SITUATION to the PATIENT other than loss of function. |
New requirement about the INTERNAL ELECTRICAL POWER SOURCE. |
|
|
201.12.1.101 Scale and calibration signal |
N/A |
N |
T |
The ELECTROENCEPHALOGRAM shall be displayed with a scale or calibration signal labelled in μV or mV. |
New requirement about scale and calibration signal. |
|
|
201.12.1.102 Accuracy of amplitude and rate of variation |
201.12.1.101.1 Accuracy of signal reproduction |
R |
T |
Add the new requirement for EEG acquisition from Cerebral cortex or subdural locations. Remove the test method with triangular wave of 2 Hz. And add test step for 6Hz Sine wave. Figure 201.104 – General test circuit was updated. |
The updated test method with sine wave and updated general test circuit need further action |
|
|
201.12.1.103 * Input dynamic range and differential offset voltage |
201.12.1.101.2 |
R |
T |
The DC offset voltage is changed from ±300 mV to ±150 mV. Figure 201.104 – General test circuit was updated. |
The updated test method with new DC offset and updated general test circuit need further action. |
|
|
201.12.1.104 Input noise |
201.12.1.101.3 |
R |
T |
The requirement is same, but the test method is different: Use the common mode rejection test circuit. |
The new test method may have impact on the input noise. |
|
|
201.12.1.105 Frequency response |
201.12.1.101.4 |
R |
T |
The requirement is same, but the test signal (50uv) and test method changed. |
The Frequency response should be retested with the new method. |
|
|
201.12.1.106 * Common mode rejection |
201.12.1.101.5 |
R |
T |
The minimum test time was reduced from 60 s to 10 s and the resistor value was changed from 51kΩ to 10 kΩ. The Figure 201.105 of test circuit for Nosie and common mode rejection was changed. |
The common mode rejection should be retested per the new requirement and test method. |
|
|
201.12.4.101 * Indication of invalid data |
N/A |
N |
T |
ELECTROENCEPHALOGRAPHS intended for unattended monitoring shall be provided with means to indicate overload, saturation of any part of the amplifier and disconnected LEAD WIRES. |
New requirement about the indication of invalid data. |
|
|
201.15.4.4.101 Indicator of operation from the INTERNAL ELECTRICAL POWER SOURCE and the status of the INTERNAL ELECTRICAL POWER SOURCE |
N/A |
N |
T |
The ELECTROENCEPHALOGRAPH shall visually indicate when it is operating from its INTERNAL ELECTRICAL POWER SOURCE, unless it is only INTERNALLY POWERED. The ELECTROENCEPHALOGRAPH shall visually indicate its remaining battery capacity when operating from its INTERNAL ELECTRICAL POWER SOURCE. |
New requirements about the internal ELECTRICAL POWER SOURCE. |
|
|
202 Electromagnetic disturbances – Requirements and tests |
02 Electromagnetic compatibility – Requirements and tests |
R |
T |
Align to IEC 60601-1-2:2014+A1:2020 |
Align to the latest EMC standard |
|
|
202.8.101 * Disturbances from HF SURGICAL EQUIPMENT |
N/A |
N |
T |
return to its previous operating mode within 30 s after exposure to disturbances produced by HF SURGICAL EQUIPMENT, without any change in operating mode and OPERATOR settings and without loss of any stored data. |
The testing should be reevaluated with the new HF and updated Figure. |
|
|
206 USABILITY |
N/A |
N |
T |
Add the new PRIMARY OPERATING FUNCTIONS (POF) for EEG device: a) switching on/off; b) connecting/disconnecting PATIENT CABLES and LEAD WIRES; c) observing waveforms from display; d) ELECTRODE impedance verification; e) measuring amplitude and frequency of EEG signals, if such measurements are provided; f) setting the OPERATOR-adjustable controls rele |
|
|
來(lái)源：MD SRE
關(guān)于我們 聯(lián)系我們 營(yíng)業(yè)執(zhí)照 全國(guó)服務(wù)電話：400-818-0021 嘉峪檢測(cè)版權(quán)所有 備案號(hào)：京ICP備14047019號(hào)-2 
京公網(wǎng)安備11010802046783號(hào)
