Pengujian Alat Kesehatan Kelistrikan

Berdasarkan SNI IEC 60601-1:2014

Asep Rahmat Hidayat

Pusat Riset Teknologi Pengujian dan

Standar - BRIN
Asep Rahmat Hidayat

Peneliti Ahli Muda

Pusat Riset Teknologi Pengujian

dan Standar BRIN

S2 Biomedical Engineering UI

asep029@brin.go.id
 Metode Pengujian Scope of General Requirements

General requirements for safety -

Collateral standard: Safety General requirements for basic safety and
General requirements for basic essential performance - Collateral Standard:
requirements for medical electrical
safety and essential performance General requirements, tests and guidance for
systems
- Collateral standard: alarm systems in medical electrical
Electromagnetic compatibility - equipment and medical electrical systems
Requirements and tests

IEC60601-1-1

General IEC60601-1-2 IEC60601-1-8

requirements
for basic
safety and IEC 60601-1 Others
essential
performance
IEC60601-1-3 IEC60601-1-6

General requirements for safety -
3. Collateral standard: General
requirements for radiation
protection in diagnostic X-ray
equipment
IEC60601-1-4
General requirements for basic
General requirements for safety - safety and essential performance
4. Collateral standard: - Collateral standard: Usability
Programmable electrical medical
systems
Metode Pengujian Scope of Particular Requirements

Particular Requirements
IEC 60601-2-”1” to “54”

General Requirements

IEC 60601-2-4
• Particular requirements for the basic safety and essential performance of cardiac defibrillators

IEC 60601-2-19
• Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and
essential performance of infant incubators

etc
IEC 60601 Series
 Standard IEC 60601 series

IEC 60601-1 Medical electrical equipment-Part 1: General requirements

for safety
IEC 60601-1-1 Medical electrical equipment-Part 1-1: General requirement
for safety – Collateral standard: Safety requirements for
medical electrical systems

IEC 60601-1-2 Medical electrical equipment-Part 1-2: General requirement

for safety – Collateral standard: Electromagnetic
compatibility – Requirements and tests.
IEC 60601-1-3 Medical electrical equipment-Part 1-3: General requirement
for safety – Collateral standard: General requirements for
radiation protection in diagnostic X-ray equipment.
IEC 60601-1-4 Medical electrical equipment-Part 1-4: General requirement
for safety – Collateral standard: Programmable electrical
medical systems
Standard IEC 60601 series
IEC 60601-2-1 Medical electrical equipment-Part 2-1: Particular
requirements for safety of electron accelerometers in the
range 1 MeV to 50 MeV
IEC 60601-2-2 Medical electrical equipment-Part 2-2: Particular
requirements for safety of high frequency surgical
equipment
IEC 60601-2-3 Medical electrical equipment-Part 2-3: Particular
requirements for safety of short wave therapy equipment
IEC 60601-2-4 Medical electrical equipment-Part 2-4: Particular
requirements for safety of cardiac defibrillator and cardiac
defibrillator monitors
IEC 60601-2-5 Medical electrical equipment-Part 2-5: Particular
requirements for safety of ultrasonic physiotherapy
equipment
IEC 60601-2-6 Medical electrical equipment-Part 2-6: Particular
requirements for safety of microwave therapy equipment
Standard IEC 60601 series

IEC 60601-2-7 Medical electrical equipment-Part 2-7: Particular

requirements for safety of high-voltage generators of
diagnostic X-ray generators
IEC 60601-2-8 Medical electrical equipment-Part 2-8: Particular
requirements for safety of therapeutic X-ray equipment
operating in the range 10 kV to 1 MV
IEC 60601-2-9 Medical electrical equipment-Part 2-9: Particular
requirements for safety of patient contact dosemeters used
in radiotherapy with electrically connected radiation detector
IEC 60601-2-10 Medical electrical equipment-Part 2-10: Particular
requirements for safety of nerve and muscle stimulators
IEC 60601-2-11 Medical electrical equipment-Part 2-11: Particular
requirements for safety of gamma beam therapy equipment
IEC 60601-2-12 Medical electrical equipment-Part 2-12: Particular
requirements for safety of lung ventilators – Critical care
ventilators
Standard IEC 60601 series

IEC 60601-2-13 Medical electrical equipment-Part 2-13: Particular

requirements for safety of anaesthetic workstations

IEC 60601-2-15 Medical electrical equipment-Part 2-15: Particular

requirements for safety of capacitor discharge X-ray
generators
IEC 60601-2-16 Medical electrical equipment-Part 2-16: Particular
requirements for safety of haemodialysis, haemodiafiltration
and haemofiltration equipment
IEC 60601-2-17 Medical electrical equipment-Part 2-17: Particular
requirements for safety of remote-controlled automatically-
driven gamma-ray afterloading equipment
IEC 60601-2-18 Medical electrical equipment-Part 2-18: Particular
requirements for safety of endoscopic equipment
IEC 60601-2-19 Medical electrical equipment-Part 2-19: Particular
requirements for safety of baby incubators
Standard IEC 60601 series

IEC 60601-2-20 Medical electrical equipment-Part 2-20: Particular

requirements for safety of transport incubators
IEC 60601-2-21 Medical electrical equipment-Part 2-21: Particular
requirements for safety of infant radiant warmers

IEC 60601-2-22 Medical electrical equipment-Part 2-22: Particular

requirements for safety of diagnostic and therapeutic laser
equipment
IEC 60601-2-23 Medical electrical equipment-Part 2-23: Particular
requirements for safety, including essential performance of
transcutaneous partial pressure monitoring equipment
IEC 60601-2-24 Medical electrical equipment-Part 2-24: Particular
requirements for safety of infusion pump and controllers
IEC 60601-2-25 Medical electrical equipment-Part 2-25: Particular
requirements for safety of electrocardiographs
Standard IEC 60601 series
IEC 60601-2-26 Medical electrical equipment-Part 2-26: Particular
requirements for safety of electroencephalographs
IEC 60601-2-27 Medical electrical equipment-Part 2-27: Particular
requirements for safety of electrocardiographic monitoring
equipment
IEC 60601-2-28 Medical electrical equipment-Part 2-28: Particular
requirements for safety of X-ray source assemblies and X-
ray tube assemblies for medical diagnosis
IEC 60601-2-29 Medical electrical equipment-Part 2-23: Particular
requirements for safety of radiotherapy simulators
IEC 60601-2-30 Medical electrical equipment-Part 2-30: Particular
requirements for safety, including essential performance of
automatic cycling non-invasive blood pressure monitoring
equipment
IEC 60601-2-31 Medical electrical equipment-Part 2-31: Particular
requirements for safety of external cardiac pacemakers with
internal power source
Standard IEC 60601 series
IEC 60601-2-32 Medical electrical equipment-Part 2-32: Particular
requirements for safety of associated equipment of X-ray
equipment
IEC 60601-2-33 Medical electrical equipment-Part 2-33: Particular
requirements for safety of magnetic resonance equipment
for medical diagnosis
IEC 60601-2-34 Medical electrical equipment-Part 2-34: Particular
requirements for safety, including essential performance of
invasive blood pressure monitoring equipment
IEC 60601-2-35 Medical electrical equipment-Part 2-35: Particular
requirements for safety of blankets, pads and mattresses
intended for heating in medical use
IEC 60601-2-36 Medical electrical equipment-Part 2-36: Particular
requirements for safety of equipment for extracorporeally
induced lithotripsy
IEC 60601-2-37 Medical electrical equipment-Part 2-37: Particular
requirements for safety of ultrasonic medical diagnostic and
monitoring equipment
Standard IEC 60601 series
IEC 60601-2-38 Medical electrical equipment-Part 2-38: Particular
requirements for safety of electrically operated hospital beds
IEC 60601-2-39 Medical electrical equipment-Part 2-39: Particular
requirements for safety of peritoneal dialysis equipment
IEC 60601-2-40 Medical electrical equipment-Part 2-40: Particular
requirements for safety of electromyographs and evoked
response equipment
IEC 60601-2-41 Medical electrical equipment-Part 2-41: Particular
requirements for safety of surgical luminaires and luminaires
for diagnosis
IEC 60601-2-43 Medical electrical equipment-Part 2-43: Particular
requirements for safety of X-ray equipment for interventional
procedures
IEC 60601-2-44 Medical electrical equipment-Part 2-44: Particular
requirements for safety of X-ray equipment for computed
tomography
Standard IEC 60601 series

IEC 60601-2-45 Medical electrical equipment-Part 2-45: Particular

requirements for safety of mammographic X-ray equipment
and mammographic stereotactic devices
IEC 60601-2-46 Medical electrical equipment-Part 2-46: Particular
requirements for safety of operating tables
IEC 60601-2-47 Medical electrical equipment-Part 2-47: Particular
requirements for safety, including essential performance of
ambulatory electrocardiographic systems
IEC 60601-2-49 Medical electrical equipment-Part 2-49: Particular
requirements for safety of multifunction patient monitoring
equipment
IEC 60601-2-50 Medical electrical equipment-Part 2-50: Particular
requirements for safety of infant phototherapy equipment
IEC 60601-3-1 Medical electrical equipment-Part 3-1: Essential
performance requirement for transcutaneous oxygen and
carbon dioxide partial pressure monitoring equipment
Metode Pengujian
Metode Pengujian
Parameter Uji
 Pasal 4
Persyaratan Umum

Menguraikan tentang:

Menjelaskan kondisi pemakaian peralatan elektromedik pada

saat pengujian.

Harus melakukan proses manajemen resiko berdasarkan ISO

14971.
Inspeksi File
Produsen harus mengidentifikasi fungsi pada peralatan Manajemen
elektromediknya Resiko

Harus menyebutkan harapan hidup (expected service life)

Menjelaskan bagian peralatan elektromedik yang kontak dengan pasien,

kondisi kegagalan tunggal, wiring diagram, sumber power suplay, dan
kinerja esensial alat, komponen, masukan daya.

Pengukuran Power Input

 Pasal 4
Persyaratan Umum
Dokumen manajemen risiko memenuhi
apabila:
Menetapkan proses manajemen risiko
Kesesuaian
Diperiksa dengan
Inspeksi
Menetapkan tingkat risiko yang dapat diterima Dokumen
Manajemen
Resiko

Menunjukan bahwa risiko residual dapat diterima (sesuai dengan kebijakan

penentuan risiko yang dapat diterima)
 Pasal 5

Menjelaskan persyaratan umum untuk pengujian

• Uji tipe
• Jumlah sampel
• Kondisi temperatur dan kelembaban lab uji harus disesuaikan dengan
kondisi kerja peralatan elektromedik
• Sebelum pengujian proteksi terhadap bahaya listrik dari peralatan
elektromedik, harus dilakukan prapengkondisian untuk kelembaban
93% ± 3%, temperatur 20 oC – 32 oC selama 48 jam
• Urutan pengujian
• Menjelaskan bagaimana cara pengujian terhadap bagian-bagian yang
dapat diakses (Test finger, test hook)
 Pasal 6

Klasifikasi peralatan elektromedik

• Pengujian berdasarkan kelas dan tipe (kelas I, II, dan tipe B,
BF, atau CF untuk applied parts)
• Pengujian IP Code (IPN1N2)
 Pasal 7

Menguji identifikasi peralatan elektromedik, penandaan dan

dokumen

• Marking harus jelas, kuat.

• Simbol-simbol harus mengacu ke ISO 60417
• Aksesoris harus ada merk pabrikan
• Penandaan catu tegangan harus jelas (100 – 240V atau 120/220/240V)
• Klasifikasi IP
• Warna kabel, lampu, harus sesuian dengan persyaratan IEC 60601
• Tanda peringatan; misalnya: Hanya boleh digunakan oleh petugas
yang terlatih
• Petunjuk penggunaan
 Pasal 8

Menguji Proteksi terhadap bahaya listrik peralatan eletromedik

• Menguji Creepage and Clearance Distance

• Pengujian Leakage Current
• Pengujian Kekuatan Dielektrik
• Pengujian material isolasi mengguakan Ball Pressure Test
• Pengujian kabel-kabel internal
 Pasal 9
Menguji Proteksi terhadap mekanis inkubator
• Bahaya mekanis ketidakstabilan
• Bahaya bagian-bagian yang bergerak
• Bahaya permukaan, sudut, bagian sisi inkubator
• Tingkat kebisingan kompartemen
• Tingkat suara alarm
• Pengujian matras
Pasal 10

Menguji Potensi terhadap bahaya radiasi yang tidak diinginkan

• Radiasi sinar X → Pengukuran
• Radiasi alpha, beta, gamma
• Radiasi gelombang microwave File Manajemen
• Radiasi elektromagnetik Resiko
• Radiasi infrared
• Radiasi UV
 Pasal 11

Proteksi terhadap temperatur yang berlebihan dan Potensi

bahaya lainnya
• Menguji temperatur yang berlebihan pada peralatan elektromedik
(komponen dan bagian yang mudah tersentuh)
• Menguji bagian-bagian yang diaplikasikan yang membangkitkan panas
• Menguji kekuatan mekanik dari selungkup (enclosure)
• Menguji proteksi terhadap tumpahan, cipratan, kebocoran, tempat
masuknya air, atau benda tertentu.
• Melihat Biokompatibilitas apabila alatnya bersentuhan dengan sel
atau jaringan biologis (harus didokumentasikan berdasarkan ISO
10993)
 Pasal 12

Keakurasian kontrol dan instrumen dan proteksi terhadap keluaran Jika dapat
yang menimbulkan potensi bahaya diaplikasikan
• Keakurasian kontrol dan instrumen
• Tingkat Kegunaan, Sistem Alarm
• Proteksi terhadap keluaran yang menimbulkan potensi bahaya
• Kesalahan dalam pemberian nilai keluaran yang berlebihan.
• Keluaran yang salah. Inspeksi
• Radiasi Diagnostik atau Terapi. Dokumen
• Peralatan sinar-X diagnostik Manajemen
Resiko
• peralatan elektromedik lain yang membangkitkan radiasi diagnostik atau
terapi (selain sinar X diagnostik dan radioterapi)
 Pasal 13
Situasi yang berpotensi bahaya dan kondisi kegagalan

• Emisi panas: timbulnya bara api, logam yang meleleh (mengukur bagian-bagian yang menimbulkan
panas)
• Arus bocor yang melampaui batas atau batas tegangan
• Potensi bahaya mekanis yang khusus (lihat 9.1 sampai dengan 9.8)
• Transformator peralatan elektromedik dengan panas berlebih / overheating
• Kegagalan thermostats
• Kebocoran cairan
• Kegagalan pendinginan yang dapat menyebabkan potensi bahaya
• Penguncian bagian yang bergerak
• Pemutusan dan Hubung Singkat Kapasitor Motor
• dll
 Pasal 14

Sistem Elektromedik terprogram (PEMS)

• Harus diuji, kecuali:
• Aplikasi dari ISO 14971 menunjukan bahwa kegagalan dari sistem
elektromedik terprogram tidak mengakibatkan risiko yang tidak
dapat diterima. Diuji kalau sesuai
• File manajemen resiko harus memasukan rancangan validasi sistem dengan produknya
elektromedik terprogram
• Siklus hidup sistem elektromedik terprogram harus terdokumentasi
 Pasal 15
Konstruksi Peralatan Elektromedik

• Kemudahan untuk perbaikan (harus didokumentasikan)

• Pengujian kekuatan mekanis
• Uji tekan (ditekan dengan gaya 250 N selama 5 detik)
• Uji benturan (bola baja diameter 50 mm dengan berat 500 gr dijatuhkan bebas dari ketinggian 1,3 m)
• Uji jatuh (untuk peralatan hand held/portabel)
• Pengujian penanganan yang kasar (didorong melewati penghalang kayu 40 mm dengan kecepatan 0.4
m/detik)
• Penandaan sensor harus jelas (mis: sensor kulit)
• Instrumen pengontrol temperatur harus dilengkapi dengan pemutus panas: mis: kelebihan temperatur
akan membunyikan alarm.
• Pengujian alarm dengan menaikan temperatur
 Pasal 16
Sistem Elektromedik

• Persyaratan untuk sistem elektromedik

• Setelah instalasi atau dimodifikasi, peralatan elektromedik tidak mengakibatkan resiko yang tidak dapat
diterima.
• Apabila digunakan bersamaan dengan alat yang lain harus didokumentasikan bahayanya.

Inspeksi Dokumen
Dokumen
Manajemen
Pendamping
Risiko
 Pasal 16
Sistem Elektromedik

• Pengujian Arus Bocor

 Pasal 17
Kompatibilitas Elektromagnetik

• Pabrikan harus menyampaikan dalam file manajemen risiko terait:

• Fenomena eletromagnetik yang ada pada lokasi dimana peralatan elektromedik
digunakan. Inspeksi Dokumen
• Pengenalan fenomena elektromagnetik dari peralatan elektromedik ke dalam Manajemen Risiiko
lingkungan yang mungkin dapat menurunkan kinerja alat lain.

• Dokumen Manajemen Risiko

• Pengujian Kompatibilitas Elektromagnetik mengacu ke IEC 60601-1-2

Terima Kasih