Obstruction alarm requirement ISO 80601-2-12

pmg76

Registered
#1
Hi all!
This is a naive question, but as I´m not a native English speaker and I have some doubts about the phrasing in the norm, I'm not completely sure about my understanding.
In ISO 80601-2-12 .201.12.4.107 - Obstruction ALARM CONDITION.
The norm states: "... The maximum ALARM CONDITION DELAY shall be no more than two breath cycles or 5 s, whichever is greater."
As I understand it, it is talking about the maximum delay between the obstruction condition and the activation of the alarm signal. But then it gives two conditional statements "two breath cycles" and "5 secs" whichever is greater.
So, there are two alternatives:
1) Two breath cycles (let's say 4 secs) are less than 5 secs => the maximum delay is 5 secs.
2) Two breath cycles (lets's say 20 sec) are more than 5 secs => the maximum delay is 20 secs.

I'm having a hard time to understand the rational behind this requirement and IMHO the norm should say "whichever is shorter", so the maximum delay can never be more than 5 secs.

I'm tempted to just use 5 secs as the maximum delay always; however I could be misunderstanding the requirement.
Can someone shed some light on this matter?
Thanks!
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I'll say out of the gate: I don't know. Maybe someone will chime in who knows for sure. I can speculate that they're trying to minimize the number of 'annoyance' alarms.
 
Thread starter Similar threads Forum Replies Date
I Cleanroom Actions in case of Actions Limit Alarm Qualification and Validation (including 21 CFR Part 11) 3
V Colour of indication for ALARM SIGNAL inactivation states IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
shimonv IEC 60601-1-8 - When does an error message become an alarm signal? IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
M Infusion Pump Power Failure Alarm IEC 60601-2-24 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Does anybody know in which Standard can this attached Alarm Symbol be found? Other Medical Device Related Standards 3
R Who is regulating Security Alarm Codes? Coffee Break and Water Cooler Discussions 8
O Upcoming IEC/ISO standard on "Distributed alarm systems" (80001-2-5) Medical Information Technology, Medical Software and Health Informatics 6
S MDD 93/42 Annex I 12.3 - Medical Device Electrical Alarm Requirements EU Medical Device Regulations 3
M AS 4706 (Personal Response Systems) & AS 3811 (Patient Alarm Systems) Equivalents? Other ISO and International Standards and European Regulations 4
Q Scope of Certification is Ringing Alarm Bells ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
A How to set Wirebond Alarm Limit? Statistical Analysis Tools, Techniques and SPC 2
M IEC EN 60601-1-8: Battery monitor considered an alarm? IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
C IEC EN 60601-1-8: What defines a visual alarm? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R Volume of Alarm Signal per IEC 60601-1-8 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J About the Intelligent Alarm System in IEC60601-1-8 (Anaesthetic Systems) IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
M IEC 60601-1-8 2006 Alarm Auditory Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
G Boss' Alarm Funny Stuff - Jokes and Humour 0
T Control Chart on Paper vs. Software where trend cannot be seen (Alarm only) Statistical Analysis Tools, Techniques and SPC 8
B Opinions on Zone Alarm Internet Security Suite After Work and Weekend Discussion Topics 2
C NFPA 72 and NFPA 72 Standards - Electrical Installation and Fire Alarm Systems Various Other Specifications, Standards, and related Requirements 3
D Training for IEC 60601-1-8:2006 Alarm Systems in Medical equipment. IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
H Recommendation for a Planning tool which gives an Alarm at Specific Time & Others. Quality Tools, Improvement and Analysis 5
P MSA Attribute Studies - Calculate Cross Tabs, Effectiveness, Miss Rate, False Alarm Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
F Risk + Disaster Assessment, Fire Alarm, etc. - Records Management Business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Jen Kirley Formatting an Excel .xls spreadsheet to alarm out-of-calibration status Excel .xls Spreadsheet Templates and Tools 11
N Effectiveness, miss rate and false alarm rate - Need formulas to calculate Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
P Miss rate & False Alarm Rate - What are they and how are they calculated? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 0
I Laboratory Fridge / Freezer Inventory - Requirement(s) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
C Industrial scales and MSA (IATF 16949 requirement 7.1.5.1.1) IATF 16949 - Automotive Quality Systems Standard 30
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
S Article 61 - MDR Clinical Investigation Requirement EU Medical Device Regulations 5
V 3 PQ lots mentioned as requirement in PPAP. Is this necessary? APQP and PPAP 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? ISO 13485:2016 - Medical Device Quality Management Systems 4
S ISO17020 - Equipment calibration requirement General Measurement Device and Calibration Topics 3
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
shimonv IEC 60601-1 Essential Performance - Is the signal accuracy specification an essential requirement? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
Ronen E Can anyone please explain this? (510k submission requirement) Other US Medical Device Regulations 14
M EU MDR - Annex II 3b - What documents fall under this requirement? EU Medical Device Regulations 3
D Vietnam requirement of CE mark for medical devices CE Marking (Conformité Européene) / CB Scheme 4
Similar threads


















































Top Bottom